Synthetic elastomeric article and method for producing same

Abstract

The present application relates to an elastomeric article, such as a glove, comprising: (i) an elastomeric film comprising one or more film layers and comprising an outer surface and an inner surface; (ii) an antimicrobial agent effective against both beneficial and harmful microorganisms, located on the outer surface of the elastomeric film; and (iii) a skin protectant selected from the group consisting of probiotics, prebiotics, or combinations thereof, located on the inner surface of the elastomeric film; wherein the inner surface of the film is free from an antimicrobial effective amount of an antimicrobial agent that is effective against both beneficial and harmful microorganisms. The elastomeric article may further comprise a barrier film layer that isolates the antimicrobial agent and the skin protectant. Methods for making such articles are also described.

Description

[0001] This application is a divisional application of the patent application with application number 202080002196.1, application date January 29, 2020, and invention name “Synthetic Elastomer Articles and Production Methods Thereof”. Technical Field

[0002] The present application relates to elastomeric articles and methods for producing the same. The articles may be of the type used for contact with human skin. For example, the articles may be in the form of gloves that have antimicrobial properties while also protecting the wearer's skin from exposure to antimicrobial agents. Background Art

[0003] In many industries, gloves, such as thin film gloves, are worn for extended periods of time to protect the wearer from potentially hazardous materials and fluids that they come into contact with during their activities. For example, in the medical industry, healthcare professionals wear gloves to reduce the risk of exposure to or transmission of pathogenic microorganisms. Gloves are made from thin films of relatively low-cost elastomers, resulting in a lower unit price for the product because gloves are expected to be changed frequently for reasons including hygiene and comfort.

[0004] Typical gloves used in these situations are formed from elastomeric films with strong barrier properties. However, while gloves provide a physical barrier to prevent direct contact and transmission of pathogenic microorganisms to the user's skin, there is still a risk that pathogens can pass through the gloves and reach the user's hands. There is also a risk that pathogenic microorganisms that come into contact with the outer surface of the glove are deposited on the glove and can then be transmitted to the glove wearer or other persons who come into contact with the outer surface of the glove by cross contamination.

[0005] Some gloves containing antimicrobial agents are available. The antimicrobial agent can provide antimicrobial properties to the gloves. The antimicrobial agent is usually present on the entire surface of the glove. However, continuous use of such gloves may cause skin problems because the user's skin is constantly exposed to the antimicrobial agent.

[0006] Applicants have observed that current antimicrobial glove technology on the market does not take into account the potential harmful effects that repeated exposure to antimicrobial agents may have on the skin.

[0007] Therefore, there is a need for new elastomeric articles and methods of producing such articles which have antimicrobial properties that protect the skin from repeated exposure to antimicrobial agents contained in the articles, or at least reduce or minimize the potential harm to the skin caused by antimicrobial agents. Summary of the invention

[0008] Applicants have developed new elastomeric articles that contain an antimicrobial agent while also protecting the user's skin from exposure to the antimicrobial agent. Applicants have discovered that by including an antimicrobial agent on the outer surface of the article and a skin protectant (selected from probiotics, prebiotics, or combinations thereof) on the inner surface of the article, the benefits of each type of agent can be obtained without adverse interactions. Applicants have surprisingly discovered that an elastomeric article can be obtained that has both antimicrobial and skin protective properties without having an inhibitory negative impact on glove properties such as elasticity, modulus (a fatigue property associated with the durability of the glove), softness, film barrier properties, and / or film thickness.

[0009] According to the present invention, there is provided an elastomeric article, the elastomeric article comprising:

[0010] - an elastomeric film comprising one or more film layers and including an outer surface and an inner surface;

[0011] - an antimicrobial agent located on the outer surface of the elastomeric film; and

[0012] - A skin protectant selected from probiotics, prebiotics or a combination thereof, located on the inner surface of the elastomeric film.

[0013] In particular, the present invention provides an elastomeric article comprising:

[0014] - an elastomeric film comprising one or more film layers and including an outer surface and an inner surface;

[0015] - an antimicrobial agent, which is effective against both beneficial and harmful microorganisms, located on the outer surface of the elastomeric film; and

[0016] - a skin protectant selected from probiotics, prebiotics or a combination thereof, located on the inner surface of the elastomeric film;

[0017] The inner surface of the film does not contain an antimicrobially effective amount of an antimicrobial agent that is effective against both beneficial and harmful microorganisms.

[0018] In addition, a method for producing an elastomeric article is provided, the method comprising:

[0019] - providing an elastomeric film comprising one or more film layers, the elastomeric film comprising first and second opposing surfaces;

[0020] - introducing an antimicrobial agent onto or into the first opposing surface; and

[0021] - Introducing a skin protectant selected from probiotics, prebiotics or a combination thereof onto or in the second opposing surface.

[0022] In order to ensure that there is no appreciable amount of antimicrobial agent present on the inner surface of the film (that is, to ensure that the inner surface does not contain an antimicrobial agent that is effective in antimicrobial amount, effective against both beneficial microorganisms and harmful microorganisms), the step of introducing the antimicrobial agent on or in the first relative surface should be performed in a manner that avoids introducing the antimicrobial agent on the second relative surface. The technical examples used to ensure that this occurs are described in the detailed description section.

[0023] In a preferred aspect, applicants have discovered that unexpected benefits occur by including a layer between the outer surface containing the antimicrobial agent and the skin protectant and the inner surface that does not contain the antimicrobial agent and the skin protectant. This layer acts as a barrier layer to help maintain the efficacy of the skin protectant.

[0024] Therefore, according to a preferred aspect, there is provided an elastomeric article, the elastomeric article comprising:

[0025] - an elastomeric film comprising one or more film layers and including an outer surface and an inner surface;

[0026] - an antimicrobial agent, which is effective against both beneficial and harmful microorganisms and is located on the outer surface of the elastomeric film;

[0027] - a skin protectant selected from probiotics, prebiotics or a combination thereof, located on the inner surface of the elastomeric film; and

[0028] - a barrier film layer that separates the antimicrobial agent from the skin protectant;

[0029] The inner surface of the film does not contain an antimicrobially effective amount of an antimicrobial agent that is effective against both beneficial and harmful microorganisms.

[0030] According to another preferred aspect, there is provided a method for manufacturing an elastomeric article, the method comprising:

[0031] - providing an elastomeric film comprising one or more film layers, the elastomeric film comprising first and second opposing surfaces;

[0032] - introducing an antimicrobial agent effective against both beneficial and harmful microorganisms onto or into the first opposing surface in a manner that avoids introducing the antimicrobial agent onto or into the second opposing surface;

[0033] - introducing a skin protectant selected from probiotics, prebiotics or a combination thereof onto or into the second opposing surface; and

[0034] - Providing a barrier film layer in the elastomeric film, which barrier film layer separates the antimicrobial agent and the skin protectant.

[0035] In the process of preparing the above-mentioned film, the applicant also found that it is possible to prepare a very effective article that is antimicrobial while avoiding excessive irritation to the skin without any skin protectant on the inner surface. In such cases, care must be taken to ensure that the antimicrobial agent is applied to the outer surface of the article, and a barrier layer is also required. According to this specific embodiment, there is accordingly provided an elastomeric article, which comprises:

[0036] - an elastomeric film comprising one or more film layers and including an outer surface and an inner surface;

[0037] - an antimicrobial agent, which is effective against both beneficial and harmful microorganisms, located on the outer surface of the elastomeric film; and

[0038] - A barrier film layer positioned between the antimicrobial agent on the outer surface of the elastomeric film and the inner surface to prevent or minimize contact between the antimicrobial agent on the outer surface of the elastomeric film and the skin contacting the inner surface of the article, wherein the inner surface of the film does not contain an antimicrobially effective amount of an antimicrobial agent that is effective against both beneficial and harmful microorganisms.

[0039] "Skin contacting the inner surface of the article" means the skin that contacts the inner surface of the article during use.

[0040] According to the present invention, there is provided an elastomeric glove produced by the above method. BRIEF DESCRIPTION OF THE DRAWINGS

[0041] The present invention will now be described in further detail, by way of example only, with reference to the following drawings, which are as follows:

[0042] Figure 1 is a schematic diagram of an elastomeric article containing a barrier layer according to an embodiment of the present invention.

[0043] Figure 2 is a schematic diagram of an elastomeric article without a barrier layer according to an embodiment of the present invention.

[0044] Figure 3 is a schematic diagram of other forms of elastomeric articles based on antimicrobial agents and barrier layers.

[0045] Figure 4 is an indicative graph of a panel showing the test results of a sample taken from a glove, indicating that the sample has an antimicrobially effective amount of antimicrobial agent on the test surface. DETAILED DESCRIPTION

[0046] Elastomeric articles and methods of manufacture according to embodiments of the present application are described in further detail in this section.

[0047] Some embodiments of the present invention involve the use of an antimicrobial agent on the outer surface of the article and a skin protectant on the inner surface of the article, and the following detailed description applies primarily to these embodiments. For embodiments involving the use of an antimicrobial agent (only) on the outer surface and the use of a barrier layer that prevents the antimicrobial agent from contacting the inner surface, it should be understood that the following description is applicable as long as features other than the skin protectant are described. Therefore, if a skin protectant is described as a key feature, then such description will be understood as a relevant description only for those embodiments and claims that explicitly require a skin protectant.

[0048] Provides antimicrobial properties to elastomeric articles while preserving beneficial skin flora

[0049] Human skin is covered with a diverse community of microorganisms, including bacteria and fungi, known as the skin flora or skin microbiome. Most of the skin flora is located in the superficial layers of the epidermis and above the hair follicles.

[0050] The skin flora consists of resident and transient flora. Resident flora is the physiological skin flora. They are usually beneficial microorganisms, have a protective effect and usually have no pathogenic effect on the skin. Transient flora are incidental microorganisms that can settle on the skin but do not adhere to it. They are transmissible and can be deposited on the skin by contact with pollutants.

[0051] Some transient flora are pathogenic or have the ability to cause disease. Physical barriers (such as gloves and medical dressings) can also be used to prevent direct contact with pathogenic transient flora and prevent their transmission to the skin. Some of these products include antimicrobial agents as an additional means to prevent the spread of pathogens to the skin, in which case the antimicrobial agent can directly or indirectly contact the user's skin. However, the antimicrobial agents commonly used for these purposes are usually strong enough to kill both pathogenic microorganisms and beneficial microorganisms on the skin. Therefore, prolonged and frequent exposure of antimicrobial agents to the skin may cause an imbalance in the skin microbial community (especially beneficial microorganisms), thereby weakening the natural skin barrier over time. This may lead to skin problems such as itching, dryness, skin sensitivity or allergies, eczema, etc.

[0052] There are some available glove products that contain a coating of a skin moisturizing composition on the inner surface of the glove (i.e., the skin contacting surface). These gloves typically provide a thin layer of a simple composition that provides significant skin moisturizing or significant skin care properties. Such glove products do not take into account the concept of providing multiple effects (antimicrobial effect and skin microbiota protection) simultaneously.

[0053] Applicants have discovered that by having an antimicrobial agent on the outer surface of an elastomeric article and a probiotic, prebiotic, or combination thereof (classified under the term "skin protectant") on the inner surface, the article can be provided with antimicrobial properties while reducing the risk of skin problems for the user due to repeated exposure to the antimicrobial agent. When the article is used, the probiotics and / or prebiotics on the inner surface of the article are transferred to the user's skin, where they can act to enhance or increase the growth of beneficial skin flora and establish a stronger skin barrier against pathogens. Thus, the probiotics and / or prebiotics can counteract the harmful effects of any antimicrobial agent that may contact the user's skin by preserving the beneficial skin flora.

[0054] The elastomeric article comprises an elastomeric film having one or more elastomeric film layers. The elastomeric film has two opposing surfaces—one surface is an outer surface (i.e., the surface facing outward or the non-skin contacting surface) and the opposite surface is an inner surface (i.e., the surface facing inward or the skin contacting surface). The antimicrobial agent is located on the outer surface of the film, and the skin protectant is located on the inner surface of the film.

[0055] Optionally, the elastomeric article may include a layer that separates the portion of the article that contains or has an antimicrobial agent from the portion that contains or has a skin protectant. This layer may be referred to as a barrier layer or an isolation layer. This layer acts as a barrier layer and does not contain any antimicrobial agent, or any probiotics or prebiotics. Therefore, this layer is referred to as a barrier layer. For example, the barrier layer may be a film layer, i.e., an elastomeric film layer, or a coating composition layer (i.e., a coating formed by a coating composition). In some embodiments, the barrier layer is specifically a barrier film layer. For articles containing an antimicrobial agent but not a skin protectant, a barrier layer is an essential feature that separates the antimicrobial agent from the inner surface of the article (e.g., a glove).

[0056] Elastomeric articles or film products (such as gloves) can be single-layer film products or multi-layer film products. In this context, the term "layer" refers to the number of elastomeric film layers (i.e., in addition to the elastomeric film layer, there may also be a layer of a coating composition or the like). In the case where the product contains a single-layer elastomeric film, a barrier layer may or may not be present. If a barrier layer is present, the barrier layer may constitute the single-layer elastomeric film layer. In such embodiments, the antimicrobial agent may be located as a coating on one side of the single-layer film layer, and the skin protectant may be located as a coating on the opposite side of the film layer, so that the film layer provides the desired barrier between the two agents. (If there is no skin protectant in the article, the antimicrobial agent may be in the coating on one side of the single-layer film layer, while the inner surface of the film does not have any antimicrobial agent). In this embodiment, the barrier layer is a barrier film layer (i.e., a barrier elastomeric film layer), which can act as a physical barrier to protect the user's skin from pathogens. The barrier film layer can also prevent or reduce the migration of antimicrobial agents on the outer surface of the article to the inner surface of the article, wherein the antimicrobial agent can adversely affect the skin flora and the beneficial effects of probiotics and / or prebiotics on the inner surface of the article. In an alternative arrangement, an elastomeric article comprising a single layer of elastomeric film can comprise: (i) an elastomeric film layer containing an antimicrobial agent, followed by (ii) a coating located on one surface (the inner surface) of the elastomeric film layer, followed by (iii) a coating containing a skin protectant located on the coating (ii). The coating (ii) thus forms a barrier layer between the antimicrobial agent and the skin protectant.

[0057] In the case of a multilayer elastomeric article, the article preferably comprises a barrier layer, or the article may not contain a barrier layer. When a barrier layer is present, one or more elastomeric film layers of the multilayer film may constitute a barrier layer. In these embodiments, the individual layers form a cohesive film so that the layers cannot be separated. To a certain extent, the layers may also be mixed. In any case, it will be understood that the multiple layers are formed (either by involving a production technology for producing film layers with different structures, or by other means), and the barrier layer is a layer derived from a film-forming composition that does not contain an antimicrobial agent and a skin protectant.

[0058] It is also possible to produce gloves without a barrier layer. If the antimicrobial agent and the skin protectant are immobilized in the respective portion of the article containing these agents (e.g., an elastomeric film layer or coating) and these agents do not migrate to other portions of the article, then the barrier layer can be omitted.

[0059] Antimicrobial Agents

[0060] The term "antimicrobial agent" means a substance that prevents, reduces or inhibits the growth of microorganisms such as bacteria, viruses, fungi, etc. In the context of the present invention, the term encompasses substances that can prevent, reduce or inhibit the growth of pathogens (i.e., microorganisms that can cause disease). Antimicrobial agents can be specifically antibacterial agents, which are agents that inhibit the growth of bacteria. This can be tested according to the procedures set forth in the examples.

[0061] Examples of suitable antimicrobial agents include:

[0062] - hydroxypyrithione compounds, such as zinc pyrithione, sodium pyrithione, potassium pyrithione, calcium pyrithione, magnesium pyrithione and copper pyrithione;

[0063] - phenolic compounds, such as phenoxyethanol, 2-phenylphenol, chlorphenesin, chlorohexylenol, phenoxyisopropanol, triclosan, salicylic acid and sodium salicylate;

[0064] - heterocyclic compounds such as pyridone ethanolamine salts, methylchloroisothiazolinone, methylisothiazolinone, diazolidinyl urea, imidazolidinyl urea, DMDM ​​hydantoin, zinc pyrrolidone carboxylate and sodium pyrrolidone carboxylate;

[0065] - quaternary ammonium salts, such as benzethonium chloride, cetylpyridinium chloride, cetyltrimethylammonium bromide and myristyltrimethylammonium bromide;

[0066] - biguanide compounds, such as chlorhexidine gluconate and polyaminopropyl biguanide;

[0067] - parabens, such as methylparaben, ethylparaben, butylparaben, propylparaben, isobutylparaben, sodium methylparaben, sodium ethylparaben and sodium propylparaben;

[0068] - organic acids and their salts, including benzoic acid, sodium benzoate, potassium benzoate, calcium benzoate, dehydroacetic acid, sodium dehydroacetate, potassium sorbate and ethylenediaminetetraacetate;

[0069] - essential oils, such as eucalyptus oil, piper betel oil, menthol, thyme oil, tea tree oil, rosemary oil, peppermint oil, ginger oil, lemongrass oil and cinnamon bark oil;

[0070] - antibiotics, such as mupirocin, fusidic acid, erythromycin, bacitracin, neomycin, polymyxin b, retapamulin, clindamycin, sodium sulfacetamide, chloramphenicol, benzoyl peroxide, and silver and silver compounds (examples include silver sulfadiazine and silver salts such as silver nitrate, silver chloride and silver oxide);

[0071] - Antiviral agents such as acyclovir, penciclovir and ganciclovir;

[0072] - antifungal agents, such as selenium sulfide and ketoconazole; and

[0073] - Antimicrobial peptides, especially including net positively charged antimicrobial peptides containing 6 to 50 amino acid residues.

[0074] In some embodiments, the elastomeric article comprises two or more different antimicrobial agents. The different antimicrobial agents may belong to the same class (eg, both may be hydroxypyrithione), or they may belong to different classes.

[0075] In some embodiments, the antimicrobial agent comprises at least one hydroxypyrithione compound. In one embodiment, the antimicrobial agent comprises zinc pyrithione and sodium pyrithione.

[0076] In some embodiments, the antimicrobial agent comprises at least one phenolic compound and at least one heterocyclic compound. In one embodiment, the antimicrobial agent comprises 2-phenylphenol and pyridone ethanolamine salt.

[0077] In some embodiments, the antimicrobial agent comprises at least one phenolic compound, at least one heterocyclic compound, and at least one essential oil. In one embodiment, the antimicrobial agent comprises phenoxyethanol, zinc pyrrolidone carboxylate, and betel oil.

[0078] Of the antimicrobial agents described, the following are most preferred:

[0079] - Hydroxypyrithione compounds: These compounds are most suitable for incorporation into latex compositions to form a latex layer containing a hydroxypyrithione antimicrobial agent. Hydroxypyrithione is available in the form of a dispersion, which is insoluble in water. Therefore, it can be incorporated into the latex and has been found to be retained in the latex film layer and not readily leached out during the leaching stage of production.

[0080] - Phenolic compounds: These compounds are best incorporated into the article by addition to the coagulant, or by application through the coating composition, or by both techniques. Phenolic compounds tend to be oily liquids with poor water solubility, yet they have high temperature stability and good efficacy against a wide range of bacteria. It has been found that they are best added through the coagulant or coating composition to obtain the best overall film properties. Alternatively, the phenolic compound can be emulsified before being added to the water-based coagulant composition, water-based coating solution or water-based latex to address the oiliness of the compound. Examples of suitable emulsifiers for this purpose include ceteareth-20, cetearyl alcohol, PEG-40, castor oil, glyceryl stearate, sodium lauryl sulfate, sodium cetearyl sulfate, cetyl palmitate, and the like. Alternatively, the oily phenolic compound can be mixed with a solubilizing agent (such as polysorbate 20, polysorbate 60, polysorbate 80) before being added to the water-based coating solution. This method can be used with any oily antimicrobial agent, not just phenolic compounds.

[0081] Among the antimicrobial agents, the following are also useful:

[0082] - Heterocyclic compounds: Those heterocyclic compounds that are effective and stable within the pH range of the latex composition are most preferred. The pH of the latex composition is generally above 7.0 (usually above 8.0 or higher).

[0083] - Quaternary ammonium salts: When used, it is preferred that these salts are introduced by addition to the coagulant and / or by addition to the coating composition.

[0084] - Biguanides: These compounds are suitable for use in the present application, but in some embodiments, the antimicrobial agent of choice is a non-biguanide antimicrobial agent.

[0085] -Parabens: These compounds can be used but are less preferred due to possible concerns about the presence of parabens in personal care products.

[0086] Organic acids and their salts, when used, should be introduced via the coagulant or coating composition. Essential oils may be used but are not particularly preferred as their antimicrobial efficacy tends to be lower compared to the other agents described herein.

[0087] However, essential oils can be used in combination with other classes of antimicrobial agents. Agents selected from the antibiotic and antiviral classes can be used in combination with another antimicrobial agent to provide broader efficacy against viruses and / or antibiotic-resistant bacteria. Any newly developed additional or alternative antimicrobial agents can be used, provided that they can be incorporated into the latex composition, coagulant and / or coating in a manner that does not compromise the film properties and does not penetrate the barrier film layer in the final product.

[0088] Those antimicrobial agents that are effective against both beneficial microorganisms and harmful microorganisms are considered to be used as the antimicrobial agents used in the present application. According to a far-fetched explanation, some technicians in the field may think that some probiotics have "antimicrobial" properties because they can provide an environment that does not promote the growth of harmful microorganisms. Therefore, in order to avoid ambiguity, it should be noted that the term "antimicrobial" means an antimicrobial agent that is effective against both beneficial microorganisms and harmful microorganisms. The effect of resisting beneficial microorganisms is at least a difference between an antimicrobial agent and a probiotic.

[0089] The specific claims of the present application limit that the inner surface of the film does not contain an effective amount of antimicrobial (that is, an antimicrobial that is effectively antagonized to both beneficial microorganisms and harmful microorganisms). Those skilled in the art will be able to perform tests to determine whether there is an effective amount of such antimicrobial on a specific surface, and satisfactorily determine that there is no (or insufficient) effective antimicrobial against beneficial microorganisms and harmful microorganisms on the surface. The example provided herein provides the guidance of the technology to be used. The test microorganism for testing the efficacy of antagonizing beneficial microorganisms is Lactobacillus casei (Lactobacillus casei). The test microorganism for testing the efficacy of antagonizing harmful microorganisms is Staphylococcus aureus (Staphylococcus aureus). The test result should show that a large amount of antimicrobial is not applied to the inner film surface of the article.

[0090] If specific testing is required to provide a uniform standard for determining compliance with the requirement that the interior surface of the film does not contain an antimicrobially effective amount of an antimicrobial agent, the following test may be applied:

[0091] Testing Procedure

[0092] 1. Prepare de Man, Rogosa, and Sharpe (MRS) agar plates using MRS agar powder.

[0093] 2. Spread 100 μL of Staphylococcus aureus dissolved in peptone water on MRS agar.

[0094] 3. Place a circular sample with a diameter of 1.6 cm from the glove sample on the plate with the surface to be tested facing downward.

[0095] 4. Incubate the plate at 36°C for 48 hours.

[0096] 5. After incubation, measure the Zone Inhibition size from the edge of the glove sample to the edge of the Zone Inhibition based on the average of three different locations allowing for variation around the sample.

[0097] 6. Repeat steps 1-5 using Lactobacillus casei instead of Staphylococcus aureus.

[0098] 7. For each test microorganism, the area size was 4 mm or less, indicating that the relevant surface of the film does not contain an antimicrobially effective amount of antimicrobial agent.

[0099] This value of 4 mm indicates that the opposing surface contains an antimicrobial agent, which may diffuse into the film to some extent, as shown in Example 8. This diffusion is hindered if certain preferred features are present in the article, such as a barrier layer with a layered filler.

[0100] In some embodiments, the interior surface may be described as being free of any antimicrobial agents (note that this term does not include probiotics and / or prebiotics).

[0101] If one knows the exact procedures used to produce the article, and the production technology does not involve applying the antimicrobial agent to or in the interior surface of the article, and it is obvious from the way it is incorporated into or on the exterior surface that any antimicrobial agent will not enter the interior surface, then these facts can be relied upon in lieu of the above test procedures. In the event that the manufacturing technology clearly avoids applying the antimicrobial agent to the interior surface of the article, this can help the manufacturer avoid the need to complete this test. However, if the manufacturing method poses a question as to whether an effective amount of the antimicrobial agent may be found on the interior surface of the article, then the above test procedures take precedence.

[0102] Incorporating antimicrobial agents into elastomeric articles

[0103] The antimicrobial agent may be included on the outer surface (ie, the non-skin contacting surface) of the elastomeric article in any manner that provides antimicrobial properties on the outer surface of the elastomeric article.

[0104] There are three main ways in which antimicrobial agents can be included on the outer surface of an elastomeric article:

[0105] (i) incorporating an antimicrobial agent into an elastomeric film-forming composition used to produce one of the film layers of the elastomeric film (which film layer will become the outermost elastomeric film layer of the film);

[0106] (ii) incorporating the antimicrobial agent into the coagulant composition used in the manufacture of the elastomeric article; and / or

[0107] (iii) applying a coating composition comprising an antimicrobial agent to an outer surface of the elastomeric article.

[0108] In the case of technique (ii), this results in the antimicrobial agent being incorporated into the first elastomeric film layer formed in the article.

[0109] The antimicrobial agent may be included on the outer surface by employing any one of these techniques (i) to (iii), or by combining two techniques (e.g., (i) and (ii), (i) and (iii), or (ii) and (iii)), or by employing all three techniques.

[0110] Preferably, the antimicrobial agent is incorporated into the film layer on the outer surface of the elastomeric article, which can be accomplished by including the antimicrobial agent in the coagulant and / or elastomeric film-forming composition used to prepare the film layer of the elastomeric article.

[0111] Below, we first describe techniques for incorporating antimicrobial agents into film-forming compositions, then describe techniques for incorporating antimicrobial agents into coagulants, and then describe coating techniques for applying antimicrobial agents to film surfaces. In subsequent sections, additional details of methods for incorporating antimicrobial agents will be described, including information on component concentrations that can be used in various formulations.

[0112] Antimicrobial agents in elastomer films

[0113] One technique for incorporating an antimicrobial agent into an elastomeric film is to include the antimicrobial agent in a latex composition (elastomeric film-forming composition) used to form the elastomeric article layer. As an example, the antimicrobial agent is mixed into the elastomeric film-forming composition, and then a former (e.g., a glove-shaped former) is dipped into the elastomeric film-forming composition to form a shaped elastomeric film layer containing the antimicrobial agent.

[0114] In embodiments where the antimicrobial agent is incorporated into the elastomeric film layer, the elastomeric article may comprise a monolayer film. In these embodiments, if the article includes a barrier layer, then the article comprises a coating containing a skin protectant and a barrier coating, the coating containing the skin protectant is located on the inner surface of the article (i.e., the skin contact surface), and the barrier coating is located between the monolayer film and the coating containing the skin protectant. In other embodiments, the elastomeric article may comprise a multilayer film having at least two layers. In these embodiments, the multilayer film comprises an outer film layer and an inner film layer, the outer film layer forming the outward-facing surface of the article, and the inner film layer in contact with the user's skin when the article is used. There may be an additional film layer between the outer film layer and the inner film layer. Alternatively, the multilayer film comprises a barrier film layer, which is located between the outer layer incorporating the antimicrobial agent and the skin protectant on the inner surface of the article. The inner film layer may be a barrier film layer, or there may be another barrier film layer between the outer film layer and the inner film layer.

[0115] Depending on the manner in which the antimicrobial agent is included in the elastomeric film-forming composition, the antimicrobial agent may migrate to the outer surface of the elastomeric article during storage, thereby providing the outer surface of the elastomeric article with antimicrobial properties. Alternatively, the antimicrobial agent may remain throughout the elastomeric film layer (matrix), but in a concentration or amount such that the outer surface of the elastomeric article has antimicrobial properties.

[0116] When the antimicrobial agent is included in the film layer, the amount of antimicrobial agent in the final elastomeric film product may be between 0.001% and 15% by weight based on the weight of the elastomeric film. This amount is based on the approximate phr content of the antimicrobial agent in the elastomeric film-forming composition used to produce the outer film layer, which allows for the addition of one or more barrier layers (when present) in the case of a multilayer film, and allows for some potential leaching of the antimicrobial agent from the film during article production.

[0117] Introduction of antimicrobial agents by incorporation into the coagulant

[0118] When making dipped elastomeric film products (such as gloves), the process generally involves dipping a former (i.e., mold) into a coagulant and then into an elastomeric film-forming composition. After the coagulant dipping step, a coagulant layer remains on the former. The coagulant layer on the former attracts the film-forming composition layer to the surface of the former, and the desired thickness of the attracted film-forming composition depends on the coagulant composition and concentration. When the film dipping step is performed, the coagulant layer interpenetrates into the elastomeric film layer attracted to the surface of the former.

[0119] The antimicrobial agent can be introduced into the elastomeric film by including it in the coagulant used to produce the elastomeric film. In the final product, the distribution of the antimicrobial agent will be consistent with the antimicrobial agent present in the coagulant composition used to prepare the elastomeric article. The concentration of the antimicrobial agent can be higher on the former contact surface, which generally becomes the outer surface of the article after the elastomeric film is peeled from the former (i.e., the peeling operation turns the article over so that the coagulant side of the film becomes the outward-facing surface of the article). The amount of antimicrobial agent in the coagulant needs to be sufficient to provide antimicrobial properties to the outer surface of the elastomeric article.

[0120] The antimicrobial agent in the form of a water-soluble liquid, water-soluble solid, emulsion or dispersion can be mixed directly into the coagulant composition. The coagulant composition can contain conventional coagulant composition components (described in further detail below), wherein the antimicrobial agent is added at 0.001% to 50% by weight, preferably 0.01% to 10%.

[0121] In embodiments where the antimicrobial agent is introduced into the elastomeric film by incorporation into the coagulant, the elastomeric article may comprise a monolayer film. In these embodiments, if the article includes a barrier layer, then the article comprises a coating containing a skin protectant and a barrier coating, the coating containing the skin protectant is located on the inner surface of the article (i.e., the skin contact surface), and the barrier coating is located between the monolayer film and the coating containing the skin protectant. In other embodiments, the elastomeric article comprises a multilayer film having at least two layers. In these embodiments, the multilayer film comprises an outer film layer and an inner film layer, the outer film layer forming the outward-facing surface of the article, and the inner film layer in contact with the user's skin when the article is used. There may be an additional film layer between the outer film layer and the inner film layer. Alternatively, the multilayer film comprises a barrier film layer, which is located between the outer layer incorporating the antimicrobial agent and the skin protectant on the inner surface of the article. The inner film layer may be a barrier film layer, or there may be another barrier film layer between the outer film layer and the inner film layer.

[0122] Providing the antimicrobial agent as a coating on the elastomeric film

[0123] In another example, the antimicrobial agent can be incorporated into the elastomeric article by applying the antimicrobial agent or a coating composition containing the antimicrobial agent to the elastomeric film product. Thus, the elastomeric article can include a coating comprising the antimicrobial agent.

[0124] In embodiments where the antimicrobial agent is present in the coating, the coating comprising the antimicrobial agent is present on the outer surface of the article. The amount of antimicrobial agent contained in the coating is sufficient to provide antimicrobial properties to the elastomeric article. It should be noted that the antimicrobial agent is only present on the outer surface of the article, not on the inner surface of the article. Therefore, the application operation needs to control the application to this single surface. Otherwise, there may be adverse interactions and / or reduced efficacy of the antimicrobial agent or the skin protectant.

[0125] A manufacturer of a product according to the present application can purchase an elastomeric article and apply a coating composition comprising an antimicrobial agent to the article, or the manufacturer can produce the elastomeric article and then apply the coating composition. Methods for making elastomeric articles that can be subjected to a coating step are described herein. The elastomeric articles subjected to a coating step can themselves contain an antimicrobial agent (and / or a probiotic, a prebiotic, or a combination thereof) in the elastomeric film, or they can be free of such agents.

[0126] Where reference is made to "providing" an elastomeric film, the expression is intended to encompass the steps of obtaining such a film from a manufacturer of such film (e.g., a glove supplier), or manufacturing steps for producing the elastomeric film. Where reference is made to a barrier layer that isolates an antimicrobial agent and a skin protectant being "provided" in an elastomeric film, the term only encompasses the steps of ensuring that the antimicrobial agent and the skin protectant are applied to opposing surfaces of the film obtained from a film supplier (e.g., a glove supplier / manufacturer), or manufacturing the glove to include or incorporate the barrier layer. Thus, in the case of manufacturing an entire glove, the method may include the following steps:

[0127] - producing an elastomeric film comprising one or more film layers, the elastomeric film comprising first and second opposing surfaces;

[0128] - introducing an antimicrobial agent onto or into the first opposing surface;

[0129] - introducing a skin protectant selected from probiotics, prebiotics or a combination thereof onto or into the second opposing surface; and

[0130] - Incorporation of a barrier layer into the elastomeric film that isolates the antimicrobial agent from the skin protectant.

[0131] The barrier layer can be an elastomeric film layer that does not contain any antimicrobial agent or any skin protectant. Alternatively, the barrier layer can be a coating between a film layer containing an antimicrobial agent and a coating containing a skin protectant, or a coating between a film layer containing a skin protectant and a coating containing an antimicrobial agent.

[0132] The barrier layer incorporation step may be omitted. This step may be omitted if the antimicrobial agent and the skin protectant are immobilized in the respective portions of the article containing these agents and these agents do not migrate to other portions of the article.

[0133] The total weight of the (dry) coating containing the antimicrobial agent (i.e., after removing solvents such as water) can be 0.001% to 30% by weight of the elastomeric article. The weight percentage (i.e., dry weight) of the coating containing the antimicrobial agent in the final product as a percentage of the article can be as low as 0.001%, 0.01%, 0.1%, 1% or 5% by weight (based on the total weight of the article). The weight percentage of the coating containing the antimicrobial agent as a percentage of the article can be less than 30%, 25%, 20%, 15%, 10% or 5% by weight of the total weight of the article. Any minimum and maximum amounts can be combined to form a range, provided that the maximum amount is greater than the minimum amount, such as, in the range of 0.1% to 25%.

[0134] In some embodiments, the antimicrobial agent accounts for about 0.001% to 75% of the total weight of the article by weight. The weight percentage (that is, dry weight) of the antimicrobial agent accounting for the article in the final product can be 0.001%, 0.01%, 0.1%, 1% or 5% (based on the total weight of the article) by weight at a minimum. The coating containing the antimicrobial agent accounts for the weight percentage of the article and can be less than 30%, 25%, 20%, 15%, 10% or 5% of the total weight of the article by weight. Any minimum amount and maximum amount can be combined to form a scope, provided that the maximum amount is greater than the minimum amount, such as, by weight in the scope between 0.1% to 5% of the total weight of the article.

[0135] In some embodiments, the total amount of antimicrobial agent in the coating is at least 5% by weight of the coating. For example, the total amount of antimicrobial agent in the coating can be a minimum of about 10%, 20%, 30%, 40% or 50% of the coating, and can be as high as 75%.

[0136] In the example of a glove weighing about 4 g (before coating), the coating composition can be applied in a typical amount of at least 0.001 mg of dry antimicrobial agent, such as at least 0.005 mg, at least 0.01 mg, at least 0.05 mg, at least 0.1 mg, at least 0.5 mg, or at least 1 mg of dry antimicrobial agent. In a preferred embodiment, the glove coating composition can be applied in an amount of about 4 mg to 1000 mg of dry antimicrobial agent, which is equivalent to 0.1% to 25% (by weight) of the total weight of the glove. In other words, the volume of the coating composition containing the antimicrobial agent picked up by the glove is about 0.1 mL or more, preferably about 0.5 mL to about 5 mL per glove. These amounts also serve as a useful guide for a range of other articles, although these amounts may vary depending on the size of the article.

[0137] Skin protectant

[0138] The term "skin protectant" is used to refer to any agent that is classified as a prebiotic or probiotic. At least one skin protectant from these categories is required on one surface of the article (usually the inner surface that contacts the wearer of the article). When such agents are mentioned to be on the surface, it is extended to cover the following: such agents are present in a film layer that defines the surface of the article (e.g., the surface on the inside of the article) in a manner that allows the article to contact the skin when used or worn. There may be a very thin additional coating (e.g., an ultra-thin polymer coating film) on the article located above the skin protectant (especially when the agent is present in an elastomeric film layer), provided that the skin protectant is able to contact and / or transfer to the wearer's skin. In some specific embodiments, the skin protectant can be in the final coating on the article, on the surface facing inwardly to the wearer's skin (when worn).

[0139] Probiotics and / or prebiotics have the ability to strengthen, supplement or enhance the growth of beneficial microorganisms colonized on the skin (i.e., resident skin flora) rather than one or more pathogens. Examples of beneficial skin microbiota include Staphylococcus capitis, Corynebacterium xerosis, Micrococcus kristinae, Micrococcus lylae, Micrococcus sedentarius, Lactobacillus pentosus, Lactobacillus gasseri, Lactobacillus salivarius, and Lactobacillus acidophillus. Examples of undesirable or pathogenic skin microbiota include Candida albicans, Staphylococcus aureus, Staphylococcus epidermis, Corynebacterium minutissimum, Propionibacterium acnes, Propionibacterium granulosum, Salmonella typhimurium, Escherichia coli, Malassezia furfur, and Pseudomonas aeruginosa.Publications demonstrating the beneficial effects of probiotics and / or prebiotics on the skin include 1. Ji Hye Jeong, Chang Y. Lee & Dae Kyun Chung (2016) Probiotic Lactic Acid Bacteria and Skin Health Critical Reviews in Food Science and Nutrition, 56: 14, 2331-2337; 2. A1-Sheraji, SH, Ismail, A., Manap, MY, Mustafa, S., Yusof, RM, Hassan, FA (2013) Prebiotics as functional foods: A review, Journal of Functional Foods, 5, 1542-1553; 3. A1-Ghazzewi, FH, and Tester RF (2014) Impact of prebiotics and probiotics on skin health, Beneficial Microbes, 5(2): 99-107; 4. Berardesca, E., Abril, E., Serio, M. and Cameli, N. (2009) Effects of topical gluco-oligosaccharide and collagen tripeptide F in the treatment of sensitive atopic skin, International Journal of Cosmetic Science, 31, 271-277.

[0140] Probiotics

[0141] The term "probiotic" encompasses beneficial microorganisms that, when given in sufficient amounts, enhance or improve the properties of the inherent skin flora, or enhance the growth of beneficial microorganisms within the skin flora. The term is extended to include live cultures, freeze-dried cultures, extracts or lysates of such microorganisms. Extracts are multi-component extracts, such as aqueous or organic extracts of microorganisms or their lysates. Probiotics can promote the skin's defense barrier by reducing the ability of pathogens to colonize on the skin. Several mechanisms of probiotic activity have been postulated, including competition with pathogens for nutrition, immunomodulation, and the production of antimicrobial metabolites. Microorganisms that are beneficial to the skin are the subject of many publications, and it is open to those skilled in the art to refer to these publications to determine whether a particular microorganism is a microorganism that is beneficial to the skin. Suitable probiotics as beneficial microorganisms are described below.

[0142] Examples of suitable probiotics include probiotics that produce lactic acid, such as Lactobacillus, Lactococcus, and Bifidobacterium. Lactobacillus subspecies include Lactobacillus brevis, Lactobacillus acidophilus, Lactobacillus casei, Lactobacillus lactis, Lactobacillus plantarum, Lactobacillus pentosus, Lactobacillus gasseri, Lactobacillus salivarius, Lactobacillus rhamnosus, Lactobacillus reuteri, Lactobacillus delbreuckii, and Lactobacillus paracasei. Lactococcus subspecies include Lactococcus lactis. Bifidobacterium species include Bifidobacterium longum, Bifidobacterium breve and Bifidobacterium infantis. Other species of Bifidobacterium, Lactococcus and Lactobacillus may also be considered, as well as those species of Bacillus, Enterococcus, Streptococcus and Saccharomyces that are classified as probiotics or show probiotic effects. These probiotics may be in the form of live cultures, freeze-dried cultures or extracts or lysates thereof.

[0143] In some embodiments, the probiotic is selected from the following (including extracts / lysates thereof):

[0144] - Lactobacillus selected from the group consisting of Lactobacillus brevis, Lactobacillus acidophilus, Lactobacillus casei, Lactobacillus lactis, Lactobacillus plantarum, Lactobacillus pentosus, Lactobacillus gasseri, Lactobacillus salivarius, Lactobacillus rhamnosus, Lactobacillus reuteri, Lactobacillus delbrueckii and Lactobacillus paracasei;

[0145] - a Lactococcus species selected from Lactococcus lactis; or

[0146] - Bifidobacterium spp. selected from Bifidobacterium longum, Bifidobacterium breve and Bifidobacterium infantis.

[0147] In some embodiments, the elastomeric article comprises two or more different probiotics. The different probiotics may be of the same species (eg, both may be Lactobacillus subspecies), or they may be of different species.

[0148] In some embodiments, the probiotic comprises Lactobacillus. In some embodiments, the probiotic comprises Bifidobacterium.

[0149] In some embodiments, the probiotic is a thermophilic bacteria, such as, hyperthermophilic bacteria. Thermophilic bacteria are microorganisms with an optimal growth temperature of 50 ° C or higher. The optimal growth temperature of hyperthermophilic bacteria is higher than 75 ° C. An example of thermophilic bacteria is Lactobacillus delbrueckii. Other examples include thermophilic bacteria isolated from hot spring water, such as, species belonging to the species of Bacillus, such as, Bacillus subtilis, Geobacillus pallidus and Anoxybacillus flavithermus. The thermophilic bacteria used in yogurt / cheese production may also be suitable, such as, Streptococcus thermophilus and Lactobacillus delbrueckii subsp.Bulgaricus.

[0150] The probiotics may be in the form of live cultures, extracts, fermentation lysates, or may be freeze-dried. In a preferred embodiment, the prebiotic is in the form of a fermentation lysate or extract, such as a fermentation lysate or extract of a Lactobacillus species. Applicants have found that probiotics in the form of fermentation lysates or extracts are compatible with the manufacturing methods for preparing the elastomeric articles described herein and can be stored at room temperature.

[0151] Prebiotics

[0152] The substance represented by the term "prebiotic" is a nutrient source for beneficial microorganisms, especially beneficial resident skin flora and / or any probiotics present. The term encompasses substances that enhance the vitality and / or activity of the beneficial microorganisms in the resident skin flora. For example, prebiotics in the form of short-chain carbohydrates (up to 10 sugar / carbohydrate units) can be fermented by beneficial resident skin flora and / or probiotics to produce short-chain fatty acids (such as lactic acid, acetic acid, propionic acid and butyric acid), and the beneficial microorganisms can use short-chain fatty acids as an energy source to enhance their growth and reproduction. Prebiotics can be metabolized by beneficial microorganisms rather than pathogens, so the vitality and / or activity of beneficial microorganisms are selectively enhanced. In other words, prebiotics are selective substrates as one or a limited number of beneficial microorganisms, but are not substances as the preferential substrates of pathogens.

[0153] Examples of suitable prebiotics include sugars such as α-glucan, β-glucan, sodium carboxymethyl β-glucan, magnesium carboxymethyl β-glucan, glucomannan oligosaccharides, inulin, fructooligosaccharides, galacto-oligosaccharides, xylo-oligosaccharides, arabinoxylan oligosaccharides, manno-oligosaccharides, pectin, lignin, psyllium, chitin, chitosan and biotin. Other examples of suitable prebiotics include phytosphingosine and its salts / derivatives such as phytosphingosine hydrochloride, lactic acid, glycomacropeptides and amino acids and peptides. Suitable prebiotics can also include prebiotics derived from plant sources such as chicory root (e.g., fructooligosaccharides, inulin), Jerusalem artichoke (e.g., fructooligosaccharides), yacon root, beet root (e.g., fructooligosaccharides), burdock root, konjac root (e.g., konjac glucomannan), yam root, dandelion greens, barley (e.g., fructooligosaccharides), wheat bran (e.g., xylo-oligosaccharides and arabinoxylan oligosaccharides), apples, oats, yeast, and brown rice.

[0154] In some embodiments, the prebiotic is selected from the group consisting of:

[0155] - sugars selected from the group consisting of α-glucan, β-glucan, sodium carboxymethyl β-glucan, magnesium carboxymethyl β-glucan, glucomannan oligosaccharides, inulin, fructooligosaccharides, galacto-oligosaccharides, xylo-oligosaccharides, arabinoxylan oligosaccharides, manno-oligosaccharides, pectin, lignin, psyllium, chitin, chitosan and biotin;

[0156] - phytosphingosine and its derivatives or salts, such as phytosphingosine hydrochloride;

[0157] -Lactic acid;

[0158] - Glycomacropeptide; or

[0159] -Amino acids and peptides.

[0160] In some embodiments, the elastomeric article comprises two or more different prebiotics. The different prebiotics can belong to the same category (eg, both can be sugars), or they can belong to different categories.

[0161] In some embodiments, the prebiotic comprises a sugar selected from the group consisting of α-glucan, β-glucan, oligofructose, inulin, and a combination of one or more thereof. In some embodiments, the prebiotic comprises a plurality of sugars, such as α-glucan, β-glucan, oligofructose, and inulin.

[0162] In some embodiments, the prebiotic may be an "isolated prebiotic". This term is used to refer to an isolated or more pure form of a prebiotic, excluding less purified plant extracts (which may contain lower levels of compounds that fall into the above-mentioned prebiotic categories). Thus, as a notable example, aloe vera (the liquid squeezed from the aloe vera plant) is not within the scope of the term "isolated prebiotic". An "isolated prebiotic" is a substance containing a prebiotic (or a combination of prebiotics) at a concentration of at least 20%, preferably at least 30%, 40%, or at least 50%, excluding water, stabilizers, and emulsifiers. Such isolated prebiotic compositions can be supplied as an aqueous solution or suspension of prebiotics. As an example, CM-glucan is an example of a commercially available β-glucan prebiotic composition. The composition comprises 2% β-glucan, about 20% stabilizers and emulsifiers (total), and the balance water by weight. Excluding the content of water and stabilizer / emulsifier, the composition is primarily prebiotic. Isolated prebiotics are less likely to cause allergy or skin sensitivity issues than complex plant extracts.

[0163] The elastomeric article may comprise at least one probiotic, at least one prebiotic, or at least one probiotic in combination with at least one prebiotic.

[0164] The skin protectant is preferably not aloe vera. The skin protectant is preferably an agent other than aloe vera or a substance derived from aloe vera.

[0165] combination

[0166] In some embodiments, the elastomeric article comprises at least one probiotic and at least one prebiotic. In such embodiments, the prebiotic may be suitably selected as a nutrient source for the selected probiotic. In these embodiments, the probiotic and prebiotic may complement each other to improve the properties of the beneficial skin flora.

[0167] In some embodiments, the probiotic is a Lactobacillus species and the prebiotic is a sugar. In one embodiment, the probiotic is a Lactobacillus species and the prebiotic is a sugar selected from the group consisting of alpha-glucan, beta-glucan, oligofructose, inulin, and combinations thereof.

[0168] Incorporating skin protectants into elastomeric articles

[0169] The skin protectant is included on the inner (skin contacting) surface of the elastomeric article. This surface typically forms the outermost surface of the article on the former when the article is on the former (during production of the article) and is then inverted to become the inner surface of the article when removed from the former.

[0170] There are two main ways in which skin protectants can be included on the interior surface of elastomeric articles:

[0171] (i) applying a coating composition comprising a skin protectant to the inner surface of an elastomeric article (the inner surface may be inverted during application so that the coating is applied to the outer surface before being inverted to form the inner surface of the article); and / or

[0172] (ii) Incorporating a skin protectant into the elastomeric film-forming composition.

[0173] The skin protectant may be included on the inner surface of the article by either or both techniques (i) or (ii).

[0174] In embodiments where the elastomeric article comprises more than one skin protectant (of the same class or of different classes), each skin protectant may be included in the article by the same or different techniques. In one example, one or more probiotics may be incorporated into a film layer on the inner surface of the article, and one or more prebiotics may be included in a coating on the inner surface of the article, or vice versa. One, some or all of the probiotics in the inner film layer may be the same as the probiotics in the coating, or they may be different. In some embodiments, the skin protectant is incorporated by one technique (in which case there is more than one skin protectant).

[0175] Preferably, the skin protectant is applied as a coating on the inner surface of the elastomeric article. The coating composition comprising the skin protectant may be a polymeric coating composition. It has been previously proposed that polymeric coating compositions be used to provide "slip" properties to elastomeric articles (such as gloves) to aid in donning, but it is not known whether such polymeric coatings include any of the agents within the scope of the skin protectants described herein.

[0176] In embodiments where the skin protectant is incorporated into one of the elastomeric film layers of the elastomeric article, the elastomeric article may be a monolayer film or a multilayer film. In the case of a monolayer film, if the article includes a barrier layer, the article may include a coating containing an antimicrobial agent and a barrier coating, the coating containing an antimicrobial agent being located on the outer surface (i.e., the surface facing outward) of the article, the barrier coating being located between the monolayer film and the coating containing an antimicrobial agent. In the case of a multilayer film, according to one option, one layer forms the barrier layer of the film, while another film layer comprises a skin protectant, the antimicrobial agent being located on the opposite side of the multilayer film compared to the film layer containing the skin protectant. The skin protectant is located on the side of the article that contacts the person using (wearing) the article.

[0177] The skin protectant can be encapsulated in an encapsulation system. The encapsulation system can be a double membrane system (e.g., a liposome produced with phospholipids such as lecithin), a micelle or other lipid or non-lipid based single membrane system, or a microcapsule. The microcapsule can be based on gelatin, shea gum, polyacetyl urea (e.g., polyoxymethylene), or a combination thereof. The encapsulation system helps to fix the probiotics and / or prebiotics on the inner surface of the elastomeric article, helping to deliver the probiotics and / or prebiotics to the user's skin.

[0178] In the following, we first describe the coating application and then describe its incorporation into the film-forming composition. In the subsequent sections, additional details of the method for incorporating the skin protectant will be described.

[0179] The skin protectant is provided as a coating on the elastomeric film

[0180] In one example, the skin protectant can be incorporated into the elastomeric article by applying a skin protectant or a coating composition comprising the skin protectant. This will form a coating on the elastomeric article. Details of suitable coating compositions will be further described below in the section describing coating techniques.

[0181] In such embodiments, the coating retained on the inner surface of the elastomeric film may comprise only the skin protectant, or it may comprise the skin protectant and one or more additional components selected from the group consisting of a coating polymer, a dispersant, an emulsifier, a solubilizer, a rheology modifier, a wetting agent, an emollient, a skin conditioner, a moisturizer, a biocide, a preservative, a silicone, a fragrance, and a pH adjuster.

[0182] In some examples herein, the coating composition comprises about 3% skin protectant, 5.6% other coating components, and the balance water. Thus, after removal of the water, the skin protectant comprises about 35% of the dry coating. Based on this operation of picking up a typical amount of 1.5 mL of the coating solution onto a medium size glove, the coating comprising 35% skin protectant comprises about 11% by weight (dry weight) of a 4 g elastomeric article. The amount of coating pickup can be as little as 0.1 mL, and can be higher than 1.5 mL. Variations can be made based on this example to make the amount of skin protectant in the coating composition lower and higher, and apply lower or higher amounts of the coating composition during the manufacture of the glove.

[0183] Thus, the total weight of the (dry) coating containing the skin protectant (i.e., after removal of solvents such as water) may be from 0.001% to 75% of the weight of the elastomeric article. The weight percentage of the coating containing the skin protectant in the final product (i.e., dry weight) of the article may be at least 0.001%, 0.01%, 0.05%, 0.1%, 0.5%, 1%, 1.1%, 1.2%, 1.3%, 2.5%, 5%, 7.5%, or 10% by weight (based on the total weight of the article). The weight percentage of the coating containing the skin protectant in the article may be less than 50%, 30%, 25%, 22.5%, 20%, 17.5%, 15%, 12.5%, 10%, 7.5%, 5%, 4%, or 3% by weight of the total weight of the article. Any minimum and maximum amounts may be combined to form a range, provided that the maximum amount is greater than the minimum amount, such as a range between 0.01% and 50%, or between 0.1% and 25%.

[0184] In some embodiments, the total amount of skin protectant in the coating is at least 5% by weight of the coating. For example, the total amount of skin protectant in the coating is about 5% to 100% by weight of the coating, or at least about 10%, 20%, 25%, 30%, or at least about 40%. The maximum amount can be 80%, 60%, 50%, or 40%, provided that the smaller amount is less than the maximum amount. The remainder can be composed of other coating components.

[0185] In the example of a glove weighing about 4 g (before coating), the coating composition may be applied in a typical amount of at least 0.001 mg of dry skin protectant, such as at least 0.005 mg, at least 0.01 mg, at least 0.05 mg, at least 0.1 mg, at least 0.5 mg, or at least 1 mg of dry skin protectant. In a preferred embodiment, the glove coating composition may be applied in an amount of about 4 mg to 1000 mg of dry skin protectant, which is equivalent to 0.1% to 25% by weight of the total weight of the glove. In other words, the volume of the coating composition containing the skin protectant picked up by the glove is about 0.1 mL or more, preferably about 0.5 mL to about 5 mL per glove. These amounts are also used as a useful guide for a range of other articles, although these amounts may vary depending on the size of the article.

[0186] The coating composition comprising a skin protectant preferably does not contain a gelling agent. The coating is preferably a non-gelling coating. The coating comprising a skin protectant preferably does not contain a hydrogel. The coating comprising a skin protectant preferably does not contain an alginate (such as sodium alginate).

[0187] Skin protectant is located in the elastomer film

[0188] Another technique for incorporating the skin protectant into an elastomeric film is by including the skin protectant in the latex composition (elastomeric film-forming composition) used to form the layer of the elastomeric article.

[0189] In embodiments where the skin protectant is incorporated into the elastomeric film, the elastomeric article may comprise a multilayer film having at least two layers. The skin protectant is incorporated into the inner film layer that contacts the user's skin when the article is in use. Alternatively, the multilayer film comprises a barrier layer between the inner film layer incorporating the skin protectant and the antimicrobial agent on the outer surface of the article. In other embodiments, the article may comprise a single layer film, and the antimicrobial agent may be formed or present in a coating on the surface of the elastomeric film, with or without a coating (forming a barrier layer) therebetween.

[0190] Depending on how the skin protectant is included in the elastomeric film-forming composition, the probiotics and / or prebiotics can migrate to the inner surface of the elastomeric article during storage, thereby providing the beneficial properties of the substance to the inner surface of the elastomeric article that contacts the user's skin. Alternatively, the skin protectant can remain throughout the elastomeric film (matrix) layer, but at a concentration or amount that allows the probiotics and / or prebiotics to provide beneficial properties to the user's skin.

[0191] Barrier layer

[0192] Optionally, the elastomeric article comprises a barrier layer located between the antimicrobial agent on the outer surface of the article and the skin protectant on the inner surface of the article. This layer acts as a barrier layer and does not contain any antimicrobial agent or skin protectant. The barrier layer is advantageous because it can prevent or reduce any antimicrobial agent or any skin protectant from passing through the layer.

[0193] The barrier layer may constitute a film layer or a coating such that the barrier layer separates the portion of the article containing or having the antimicrobial agent from the portion of the article containing or having the skin protectant.

[0194] The thickness of the barrier layer may be between 0.002 mm and 2 mm.

[0195] Barrier film layer

[0196] In some embodiments, the barrier layer is in the form of an elastomeric film layer. The barrier film layer resists penetration of the antimicrobial agent and contact of the antimicrobial agent with the user's skin. In addition, the barrier film layer resists penetration of the antimicrobial agent and contact of the antimicrobial agent with the skin protectant on the inner surface of the article.

[0197] In embodiments where the elastomeric film of the elastomeric article is a single-layer film, the single-layer elastomeric film constitutes a barrier film layer that isolates the antimicrobial agent and the skin protectant. In these embodiments, each of the antimicrobial agent and the skin protectant is applied as a coating on opposite sides of the barrier film layer.

[0198] In embodiments where the elastomeric film is a multi-layer film, at least one of the film layers of the multi-layer film constitutes a barrier film layer that separates the antimicrobial agent from the skin protectant. For example, in an elastomeric film comprising two layers, the outer film layer may incorporate the antimicrobial agent and the inner film layer may be a barrier film layer. In this case, the skin protectant is included in a coating on the inner surface of the article (i.e., on the inner film layer).

[0199] The thickness of the barrier film layer may be between 0.005 mm and 2 mm. In some embodiments, the minimum thickness corresponds to a fraction of the total film thickness, for example, based on the percentage of the barrier film layer thickness to the total thickness of the multilayer film, it may be at least 10% of the total film thickness. The maximum thickness corresponds to the total thickness of the elastomeric film, as long as the antimicrobial agent and the skin protectant can form a very thin coating on the single elastomeric film layer that constitutes the barrier film layer.

[0200] The barrier film layer is preferably an elastomeric film-forming polymer, which may be selected from rubber and synthetic rubber (natural or synthetic), nitrile, self-crosslinking nitrile, polyurethane, polyisoprene, polychloroprene, polyvinyl chloride, polybutadiene, polyacrylonitrile butadiene rubber, polystyrene butadiene rubber, fluoroelastomer, butyl rubber, acrylic polymer (including acrylic diene block copolymer), polyvinyl pyrrolidone, polysiloxane and copolymers thereof with other polymers / monomers (random copolymers, block copolymers or other copolymers). Modified forms of these polymers or copolymers (e.g., polymers containing additional substituents, such as carboxylates, sulfonates, halides or other substituents) are also encompassed. The polymer may be carboxylated or non-carboxylated.

[0201] The barrier layer may contain fillers. Although such fillers are not essential to the barrier layer, they can improve the barrier properties between the antimicrobial agent and the skin protectant. Fillers can help resist or prevent the antimicrobial agent from migrating to the skin contact side (e.g., the wear side) of the article. The barrier layer (with or without fillers) also resists or prevents microorganisms from invading the skin contact side of the article.

[0202] When filler exists, it is preferably a lamellar filler.Lamellar filler is a filler with lamellar (lamellar), layered (layered) or sheet (platelet) form.Lamellar filler maintains its shape because it does not crosslink with the elastomer forming the elastomeric film.The example of lamellar filler includes lamellar minerals, clay, fiber and the like, including lamellar talc, kaolin and mica.The filler can be a conventional lamellar filler with a lamellar index (lamellarity index) of about 2-8, or a high-layer filler with a lamellar index of about 9-14 is used in some embodiments.Compared with the sheet thickness, the filler with a higher lamellar index has a larger surface area.Such high-layer fillers can enhance the physical barrier film layer.This improves the efficacy of the elastomeric article as a physical barrier against pathogens, and can further resist any potential migration of the antimicrobial agent on the outer surface of the article to the inner surface of the article.In an alternative embodiment, non-lamellar fillers can be used, although with regard to limiting or slowing down the diffusion of liquid and gas on the whole film, they do not have the benefit of lamellar fillers. Examples of non-lamellar fillers may include fiber, cellulose, calcium carbonate, and barium sulfate.

[0203] Barrier coating

[0204] In some embodiments, the barrier layer is a coating present between the portion of the elastomeric article containing the antimicrobial agent and the portion of the elastomeric article containing the skin protectant.

[0205] In these embodiments, the elastomeric film of the elastomeric article is typically a monolayer film, but may alternatively be a multilayer film. A barrier coating may be present between the film layer containing the antimicrobial agent and the coating layer containing the skin protectant. Alternatively, a barrier coating may be present between the film layer containing the skin protectant and the coating layer containing the antimicrobial agent.

[0206] The thickness of the barrier coating may be between 0.002 mm and 0.050 mm. For example, the thickness of the barrier coating may be between 0.002 mm and 0.010 mm, such as a thickness of about 0.003 mm or about 0.004 mm.

[0207] The barrier coating is preferably in the form of a polymer coating.The coating composition may comprise a coating polymer or polymer emulsion, such as a polyacrylate emulsion, a polyurethane emulsion, a silicone emulsion, a paraffin wax, a polyethylene wax or a combination thereof.

[0208] No barrier layer

[0209] The barrier layer is a physical barrier that separates the portion of the elastomeric article containing the antimicrobial agent from the portion of the elastomeric article containing the skin protectant. This prevents or reduces the likelihood that the antimicrobial agent and the skin protectant will interact with each other, thereby allowing each component to function more effectively independently. However, gloves without a barrier layer can also be produced. For example, if the antimicrobial agent and the skin protectant are fixed in the corresponding portion of the article containing these agents (e.g., an elastomeric film layer or coating), these agents will not migrate to other parts of the article, then the barrier layer can be omitted.

[0210] Elastomer products

[0211] Examples of elastomeric articles that benefit from having an antimicrobial agent on the outer surface and a skin protectant on the inner surface include: wearable articles, including gloves (covering disposable gloves, surgical gloves, examination gloves, industrial gloves, laboratory gloves, irradiation gloves, clean room gloves for the electronics industry, gloves for food contact and food processing and biotechnology applications, household gloves, lining gloves, etc.), finger cots, footwear (such as foot covers, socks, booties), medical dressings, etc. These articles are suitable disposable elastomeric articles - lightweight and low cost, suitable for use and disposal after a period of time. These articles can be film articles. These articles can be dipped articles (i.e., articles produced from dipped elastomeric films, compositions that can be applied by dipping or other means). The former used for the dipping process is formed according to the type of article - formed into a hand shape for gloves, formed into a finger shape for finger cots, or formed into a foot shape for footwear. These articles are not limited to dipped articles, and also cover articles such as extruded elastomeric articles and medical dressings.

[0212] The thickness of the elastomeric film (including any coating applied to the article) can be, for example, in the range of 0.01-3.0 mm, such as 0.01-2.0 mm, 0.01-1.0 mm, 0.01-0.3 mm, 0.02-0.2 mm, 0.05-0.10 mm, 0.03-0.08 mm, or 0.05-0.08 mm (for thin or disposable gloves and articles), and 0.2-3.0 mm for thick gloves and articles. The thickness is suitably measured as the "average thickness" of the article. For gloves, the thickness is measured according to ASTM D6319 using the average of the thickness values ​​measured at the cuff, palm, and finger locations. Finger thickness is measured at 13 mm + / - 3 mm from the fingertips; palm thickness is measured at the center of the palm, and cuff thickness is measured at 25 mm + / - 5 mm from the edge of the cuff. Perform thickness measurements on any elastomeric article according to the procedures specified in ASTM D3767-03 (revised 2014).

[0213] Despite the inclusion of antimicrobial agents and skin protectants, the elastomeric articles described herein substantially retain the appropriate elastomeric properties of the base elastomeric film. In fact, the presence of antimicrobial agents and / or skin protectants may result in desired changes in certain properties of the film. In some embodiments, the presence of antimicrobial agents and skin protectants provide good softness and lower modulus. The softness may be greater than a comparative product without an antimicrobial agent. The softness may be greater than a comparative product without an antimicrobial agent and a skin protectant. These properties may serve to minimize hand fatigue, thereby increasing the wearer's productivity when muscle exertion is low during work.

[0214] In some embodiments, the modulus of the article at 500% is less than 15 MPa. For example, the modulus at 500% can be as high as 10 MPa, or between 2 and 10 MPa, or up to 8 MPa, or up to 6 MPa. In some embodiments, the modulus is higher than a comparative product without an antimicrobial agent, indicating higher softness. As shown in the examples, the modulus can be about 4% to 80% higher than a control or comparative product without an antimicrobial agent, such as 4% to about 50%.

[0215] In some embodiments, the article has a modulus of less than 10 MPa at 300% elongation. For example, the modulus may be between 1 and 10 MPa, between 1 and 5 MPa, or between 1 MPa and 4 MPa.

[0216] It should be noted that the modulus values ​​(at 300% and 500% elongation) are based on unaged films. The ranges shown may also apply to aged films.

[0217] In some embodiments, the elastomeric article has a tensile strength of at least 8 MPa (eg, 8 MPa to 50 MPa, at least 14 MPa, or 14 MPa to 25 MPa).

[0218] When the tensile strength of the article of the present application is compared with the tensile strength of the same article without antimicrobial agent, it is expected that there is a minimum change. In some embodiments, the change in tensile strength is no more than 50%, 40%, 30%, 20% or 15% with the comparative article without antimicrobial agent. With reference to the examples shown herein, the tensile strength of an exemplary product containing 1phr of ZPT antimicrobial agent is 16.17MPa, while the tensile strength of another product containing 4phr of ZPT is 21.29MPa, which is respectively 13% lower than the control product (21.29MPa) and just less than 15% higher. These values ​​are within 15% (plus or minus) of the control.

[0219] In some embodiments, the elongation at break of the elastomeric article is at least 200% (e.g., between 200% and 1000%, between 300% and 1000%, between 400% and 1000%, between 500% and 1000%, from 600% to 1000%, or from 700% to 1000%). In some embodiments, the elongation at break of the elastomeric article is at least 500%.

[0220] The elongation at break of the product of the present application may be slightly lower than the elongation at break of the comparative product or control product without the antimicrobial agent. Preferably, the elongation at break is no less than 20% and preferably no less than 15% of the elongation at break of the control product without the antimicrobial agent. In some cases, the elongation at break may be higher than the elongation at break of the comparative product, which may be 10%, 15% or 20% higher.

[0221] One, two or all of the modulus, tensile strength and elongation at break values ​​of the elastomeric article may be within the ranges indicated above.

[0222] Weight, thickness, modulus, tensile strength, and elongation may be calculated based on a sample of at least 10 articles (eg, gloves or cots).

[0223] Elastomer film-forming composition

[0224] In the following sections, the components of the elastomeric film-forming composition used to produce a layer or each layer of the elastomeric film are described. As described above, one or more layers of the elastomeric article may contain (a) an antimicrobial agent, or (b) a skin protectant. There may be layers that do not contain these agents, such as the barrier layer of the film (if present). Therefore, the following description applies to any of these layers, provided that the composition may also contain an antimicrobial agent or a skin protectant, depending on the embodiment and the layer formed.

[0225] The elastomeric film-forming composition from which the elastomeric film is made comprises an elastomer and one or more crosslinking agents in a liquid medium. The liquid medium is typically water.

[0226] The total solids content of the elastomeric component of the elastomeric film-forming composition is from 5% to 60% by weight of the composition. The percentage of total solids content (TSC%) can vary within this range. In some embodiments, the total solids content is about 5% to 50%, 10% to 50%, 20% to 50%, or 5 to 40%.

[0227] The elastomeric film may be a self-supporting film or an unsupported film. A self-supporting film or an unsupported film is a film that exists in the absence of other structural components or layers to which it may adhere or attach.

[0228] The expressions "latex" or "rubber" are also commonly used in the art to denote any elastomer in a general sense. Therefore, especially in the following examples, it should be understood that these terms have been used as shorthand to denote the elastomer of the dipping composition.

[0229] Elastomer

[0230] Elastomer forming polymers include natural rubber and synthetic elastomer forming polymers, which can be cross-linked to produce elastomeric films. The polymer can be a single polymer or a combination of two or more polymers. The polymer can be a homopolymer or a copolymer, or a blend of a polymer / copolymer.

[0231] The elastomer-forming polymer may be selected from rubber (natural or synthetic), nitrile rubber, silicone rubber, polyvinyl chloride, polyethylene, polypropylene, polyurethane, polyisoprene, polychloroprene, polybutadiene, polyacrylonitrile butadiene rubber, polystyrene butadiene rubber, fluoroelastomers, butyl rubber, acrylic polymers (including acrylic diene block copolymers), and copolymers thereof with other polymers / monomers (random copolymers, block copolymers or other copolymers). Modified forms of these polymers or copolymers (e.g., polymers containing additional substituents, such as carboxylates, sulfonates, halides or other substituents) are also contemplated. The polymer may be carboxylated or non-carboxylated.

[0232] A notable example of synthetic elastomer forming polymer is polyacrylonitrile butadiene. It can be carboxylated or non-carboxylated. It can be provided as a mixture of carboxylated nitrile latex and acrylonitrile rubber. Another example of suitable elastomer forming polymer is self-crosslinking nitrile latex.

[0233] "Carboxylation" means the presence of carboxylate (carboxylic acid or ester) groups on the polymer chain. Carboxylation can be achieved by forming a polymer with a monomer containing a carboxylate group or by grafting the carboxylate group onto a polymer. As examples of suitable carboxylated polymers, reference is made to PCT / AU2014 / 000726 and PCT / AU2014 / 000727, the entire contents of which are each incorporated herein by reference.

[0234] In the field of the present invention, it is common practice to express the amount of elastomer as 100 phr (per 100 parts of "rubber") and to calculate the relative amounts of the remaining components of the elastomeric composition as parts (by weight) relative to 100 phr of elastomer. Thus, if the amount of crosslinker is 1 / 100 by weight of the elastomer in the composition, the amount of crosslinker is expressed as 1.0 phr.

[0235] Crosslinking agent

[0236] The elastomer film-forming composition comprises a crosslinking agent. The elastomer-forming polymer can be crosslinked with one or more crosslinking agents to produce an elastomer film. Various types of crosslinking agents can be used. The crosslinking agent category includes ionic crosslinking agents and covalent crosslinking agents. The one or more crosslinking agents used to produce the elastomer film can be selected from ionic crosslinking agents, covalent crosslinking agents, and combinations thereof. The selection will depend on various factors, including the characteristics of the desired film and the selection of the elastomer.

[0237] Ionic crosslinking agents include metal oxide crosslinking agents such as zinc oxide and magnesium oxide, peroxides such as 1,1-di(tert-butylperoxy)-3,3,5-trimethylcyclohexane, which can be purchased under the trade name Trigonox 29-40B-pd, trivalent metal-based crosslinking agents such as sodium aluminate. The trivalent metal crosslinking agent can be dissolved to generate a negatively charged multivalent metal complex ion.

[0238] Covalent crosslinking agents include organic crosslinking agents, sulfur and / or sulfur donors, and combinations thereof.The elastomeric film-forming composition may contain sulfur, or it may be sulfur-free.

[0239] Sulfur can be added in the form of elemental sulfur. Sulfur donors are another way to provide sulfur crosslinking. Sulfur donors release sulfur, or act with sulfur-containing compounds to accelerate sulfur-based covalent crosslinking of elastomer-forming polymers. These sulfur donors may also be referred to as accelerators. Examples of suitable sulfur donors include carbamates, such as thiocarbamates (e.g., zinc dibutyl dithiocarbamate (ZDBC), zinc diethyl dithiocarbamate (ZDEC), zinc dimethyl dithiocarbamate (ZDMC); thiurams (e.g., tetraethylthiuram disulfide (TETD), tetramethylthiuram disulfide (TMTD)); dipentamethylenethiuram tetrasulfide (DPTT), dipentamethylenethiuram hexasulfide (DPTH ); dipentyl methylene thiuram hexasulfide; thioureas (ethyl thiourea (ETU) and diphenyl thiourea (DPTU)); thiazoles (e.g., mercaptobenzothiazole (MBT), mercaptobenzothiazole disulfide (MBTS), zinc 2-mercaptobenzothiazole (ZMBT)), guanidines (e.g., diphenylguanidine (DPG)), and aldehyde / amine-based sulfur donors (e.g., cyclohexamethylenetetramine). Other examples are well known in the art and can be obtained from various publicly available resources.

[0240] Broadly speaking, any amount of crosslinking agent can be used depending on the desired properties of the final product. Thus, the total amount of crosslinking agent in the composition can be between 0.01 and 14 phr. The total amount of crosslinking agent can be in one of the following ranges: 0.01-8 phr, 0.1-6 phr, 0.1-5 phr, or 0.01-1.0 phr.

[0241] The amount of ionic crosslinking agent may be between 0.0-4.0 phr, such as 0.01-4.0 phr. The amount is preferably lower, 0.01-3.0 phr or 0.01-2.0 phr, 0.01-1.0 phr or 0.01-0.5 phr.

[0242] The amount of sulfur may be between 0.0-5.5 phr. The amount may be lower, 0.03.5 phr, such as 0.01-3.0 phr, 0.01-2.0 phr, 0.01-1.5 phr, 0.01-1.0 phr or 0.01-0.5 phr.

[0243] The amount of sulfur donor (eg, promoter) may be between 0.0-2.0 phr, such as between 0.1-1.5 phr, 0.1-1.0 phr, 0.2-1.0 phr, 0.3-2.0 phr, 0.3-1.5 phr, or 0.2-0.6 phr.

[0244] Other components of the elastomeric film-forming composition

[0245] The elastomeric film may further comprise an elastomer

[0246] One or more of the following conventional components of the film-forming composition: plasticizers, antioxidants, antiozonants, stabilizers (e.g., pH stabilizers), pH adjusters (e.g., agents for increasing the pH value, such as potassium hydroxide, ammonia, sodium hydroxide, or mixtures thereof), surfactants, emulsifiers, antioxidants, polymerization initiators, pigments, fillers, opacifiers, colorants, rubber deodorants / deodorants, wetting agents, defoamers, and sensitizers. These agents and their amounts and examples are described in PCT / AU2014 / 000726 and PCT / AU2016 / 050308; the entire contents of each of which are incorporated herein by reference.

[0247] Optional antimicrobial agents in elastomeric film-forming compositions

[0248] In some embodiments, the elastomeric film-forming composition of the layer from which the elastomeric film is made contains one or more antimicrobial agents. In embodiments where the elastomeric article comprises a barrier film layer, another film layer will form the barrier film layer, which does not contain an antimicrobial agent (and does not contain a skin protectant). In embodiments where the elastomeric article is a dipped article, this is typically the first film layer that terminates on the outwardly facing surface of the article when the article is turned over by peeling from the former.

[0249] The antimicrobial agent in the first elastomeric film-forming composition may be a pyrithione antimicrobial agent.

[0250] When incorporated by this technique, the antimicrobial agent may be present in the elastomeric film-forming composition at a concentration of about 0.01 phr to 20 phr. In some embodiments, the maximum amount is 15, 10, 5, or 3 phr. In some embodiments, the minimum amount (when present) is 0.01, 0.05, 0.1, 0.5, 1.0, or 2 phr. Any maximum and minimum amounts may be combined to form a range. Suitable ranges include 0.05 to 15 phr, 0.1 to 10 phr, 0.5 to 5 phr, and 2 to 3 phr.

[0251] Optional skin protectants in elastomeric film-forming compositions

[0252] In some embodiments, the elastomeric film-forming composition of the layer of the elastomeric film contains one or more skin protectants selected from probiotics and / or prebiotics. In embodiments where the elastomeric article is a dipped article, this is typically the final film layer (final elastomeric film dip layer) which becomes the inward facing surface of the article when the article is turned over by peeling from the former. For example, for a multilayer film having two layers, the elastomeric film-forming composition containing the skin protectant will be the second elastomeric film-forming composition, used to form the second film layer. For a multilayer film having three layers, this composition will form the third film layer.

[0253] In some embodiments, the skin protectant comprises a probiotic that is a thermophilic bacterium, such as a hyperthermophilic bacterium. These types of probiotics are preferred when incorporated into the film-forming composition because the composition is maintained at an elevated temperature during dipping and drying, and the probiotics preferably can withstand these thermal conditions.

[0254] The probiotics may be present in the elastomeric film-forming composition at a concentration of at least about 0.001 phr, preferably 0.01 to 50 phr. These amounts apply to the total amount of all probiotics in the film-forming composition.

[0255] Additionally or alternatively, the skin protectant may contain prebiotics. Prebiotics may be present in a concentration of at least about 0.001 phr, preferably 0.01 to 50 phr (ie, the total concentration of all prebiotics).

[0256] When a skin protectant is present in the film-forming composition, the amount of skin protectant added to the latex composition will depend on the type of elastomer and cross-linking agent used. In some embodiments, the total amount of skin protectant in the elastomeric film-forming composition is at least about 0.001 phr, preferably about 0.01 to about 50 phr. In some embodiments, the maximum amount is 40, 30, 20, 15, 10, 5 or 3 phr. In some embodiments, the minimum amount (when present) is 0.01, 0.05, 0.1, 0.5, 1.0 or 2 phr. Any maximum and minimum amounts can be combined to form a range. Suitable ranges include 0.05 to 20 phr, 0.1 to 10 phr, and 0.5 to 5 phr.

[0257] Optional Barrier Film Layer Components

[0258] In some embodiments, the barrier film layer is produced by an elastomer film-forming composition. The barrier film layer forming composition does not contain antimicrobial agents and skin protectants. Alternatively, the barrier film layer composition can contain a lamellar filler. The amount of the lamellar filler is preferably at least 0.05phr, preferably a maximum of 70phr. In some embodiments, the maximum amount is 60, 50, 40, 30, 20, 15, 10, 5 or 3phr. In some embodiments, the minimum amount (when present) is 0.05, 0.1, 0.5, 1.0, 1.5 or 2phr. Any maximum and minimum amounts can be combined to form a range. Suitable ranges include 0.5 to 20phr, 0.1 to 10phr and 0.5 to 5phr.

[0259] Formulations of Elastomeric Film-Forming Compositions Used in Embodiments of the Invention

[0260] In some embodiments, the elastomeric composition for forming the film layer of the elastomeric article comprises:

[0261] (a) dispersions of film-forming elastomers (such as nitrile, natural rubber, self-crosslinking nitrile latex, polychloroprene, polyisoprene, polyurethane, polyacrylate, polyvinylpyrrolidone, polystyrene butadiene rubber, fluoroelastomer, butyl rubber, polyvinyl chloride, polybutadiene, polysiloxane or mixtures thereof);

[0262] (b) optionally, an antimicrobial agent, or optionally, a skin protectant, or optionally, a lamellar filler (as mutually exclusive alternatives);

[0263] (c) a pH adjusting agent (such as potassium hydroxide, ammonia, sodium hydroxide or a mixture thereof);

[0264] (d) one or more cross-linking agents (such as sulfur, sulfur donors, metal oxides, ionic cross-linking agents, etc.);

[0265] (e) optionally, an accelerator (such as dithiocarbamate, thiuram, mercapto, etc.); and

[0266] (f) Optionally, one or more additional components selected from antioxidants, antiozonants, wetting agents, emulsifiers, defoamers, stabilizers, rubber deodorants, color pigments, opacifiers, etc.

[0267] In some embodiments, the elastomeric composition is accelerator-free. In some embodiments, the crosslinking agent in the elastomeric composition is sulfur-free.

[0268] Preparation of elastomeric products

[0269] The elastomeric film-forming composition having the desired components is formed into the shape of the desired article and then cured. In a broad sense, curing refers to the stage where cross-linking is performed. Such curing conditions are known in the art.

[0270] For dipped elastomeric articles, the elastomeric film is suitably prepared by a dipping process.

[0271] Briefly, in one embodiment of the present invention, a method for making an elastomeric article may include:

[0272] - dipping the mould into the coagulant composition;

[0273] - dipping the mold impregnated with the coagulant into the first elastomeric film-forming composition to produce a first elastomeric film layer on the mold;

[0274] - incorporating an antimicrobial agent into the coagulant composition and / or the first elastomeric film-forming composition to incorporate the antimicrobial agent into the first film layer defining the first surface of the elastomeric film;

[0275] - dipping the mould with the first elastomeric film layer into a second elastomeric film-forming composition free of antimicrobial agent and free of skin protectant to produce a barrier film layer;

[0276] - optionally, dipping the mould into a further elastomeric film-forming composition before or after dipping into the second elastomeric film-forming composition; and

[0277] - (a) dipping a mould comprising the elastomeric film layer into a third elastomeric film-forming composition comprising a skin protectant, or (b) applying a coating composition comprising a skin protectant onto the elastomeric film layer such that the skin protectant is present in or on the second surface of the elastomeric film.

[0278] Although the above series of steps outlines a technique for producing an elastomeric article, changes may be made to the process as described in detail below. It should be understood that other changes may be made to the process as known or described in the art. The steps for making an elastomeric film or article may be generally described in PCT / AU2014 / 000726 and PCT / AU2014 / 000727, both of which are incorporated herein by reference.

[0279] For example, the method may include:

[0280] - dipping the mould into the coagulant composition;

[0281] - dipping the mold impregnated with the coagulant into the first elastomeric film-forming composition to produce a first elastomeric film layer on the mold;

[0282] - incorporating an antimicrobial agent into the coagulant composition and / or the first elastomeric film-forming composition to incorporate the antimicrobial agent into the first film layer defining the first surface of the elastomeric film;

[0283] - optionally, dipping the mould into a further elastomeric film-forming composition before or after dipping into the second elastomeric film-forming composition; and

[0284] - (a) dipping a mould comprising the elastomeric film layer into a third elastomeric film-forming composition comprising a skin protectant, or (b) applying a coating composition comprising a skin protectant onto the elastomeric film layer such that the skin protectant is present in or on the second surface of the elastomeric film.

[0285] Optional step (a) immersing the former into a coagulant solution containing metal ions

[0286] Dipping the former into the coagulant composition is an optional step in the process for producing a dipped elastomeric article. The charged ions in the coagulant form a charged ionic coating on the former that can, through charge interactions, help control the amount of elastomeric film-forming composition that will remain on the surface of the former after subsequent dipping into the film-forming composition. If the antimicrobial agent is added via the coagulant dip, then the coagulant dip step is performed with the antimicrobial agent in the coagulant composition.

[0287] Coagulants include charged ions, such as metal salt ions. Examples of such metal salt ions are sodium, calcium, magnesium, barium, zinc and aluminum. Preferred metals are polyvalent metals. Counterions can especially be halides (such as chlorides), nitrates, acetates or sulfates. In the case of calcium-containing coagulants, calcium ions can be provided in the form of solutions of calcium nitrate or calcium chloride. Other selectable components of coagulants can include biocides (for embodiments in which biocides are introduced by coagulants), wetting agents (such as fatty alcohol ethanolates or other suitable surfactants), antitack agents, defoamers and / or release agents (such as silicon emulsions), polymer release agents and metal stearates (such as zinc stearate, calcium stearate and potassium stearate).

[0288] The concentration of the metal salt as an ion source in the coagulant may be broadly in the range of 0.0-50% (by weight) of the coagulant composition, depending on the desired thickness of the elastomeric film layer and the number of layers to be applied (i.e., one layer or two or more layers). In the case of thinner layers, the metal salt concentration is suitably in the following ranges: 0.0-20%, 0.0-15%, 0.0-12%, 1.5-20%, 1.5-15%, 1.0-10%, 1.5-10%, 4-10%, 5-10%, 5-35%, 10-30%, 7-40%, 8-50% and 5-45%. The amount of other optional components (such as wetting agents and anti-adhesive agents) depends on the properties desired to be obtained by using these agents and will vary accordingly.

[0289] In some embodiments, the coagulant composition contains an antimicrobial agent or a mixture of antimicrobials as described above. Among the described antimicrobials, the most suitable antimicrobial agents included in the coagulant composition are phenolic compounds, heterocyclic compounds and quaternary salt compounds, such as 2-phenylphenol, pyridone ethanolamine salt or a combination thereof. In such embodiments, the (total) amount of the antimicrobial agent present in the coagulant composition is at least about 0.001% by weight. The amount of the antimicrobial agent in the coagulant composition can be up to about 50% by weight. The minimum amount can be at least 0.01%, 0.1%, 0.5% or 1% by weight. The maximum amount can be 40%, 30%, 20% or 10% of the composition by weight. Any minimum amount and maximum amount can be combined without restriction to form a range, and a useful range is 0.01% to 10%.

[0290] The antimicrobial agent in such an embodiment can be incorporated into the coagulant by adding the antimicrobial agent (pure, as a water-soluble liquid or water-soluble solid, or as an emulsion, solution or dispersion) to the coagulant composition, or by formulating the coagulant with the antimicrobial agent as a component of the coagulant. Once the coagulant coating is applied to the former by dipping, and the first layer of the elastomeric film-forming composition is applied to the coagulant coating, the components of the coagulant including the antimicrobial agent will partially penetrate into the film-forming composition layer to be present on / in the area of ​​the elastomeric film layer in contact with the coagulant. In an embodiment where the elastomeric article comprises a barrier film layer, in this case, a second film layer is preferably applied to form a barrier layer between the first film layers containing the antimicrobial agent with the coagulant. If the antimicrobial agent is added via the coagulant composition, then the antimicrobial agent applied by the coagulant dipping step will not penetrate or diffuse into the first film layer to a high degree, and will not diffuse into any film layer applied subsequently. In this embodiment, the second film layer applied after the first film layer may constitute a barrier film layer. However, it is still possible to produce a product having an antimicrobial agent in the coagulant layer, a single elastomeric film as a barrier film layer (particularly where the single film layer contains a lamellar filler to prevent migration of the antimicrobial agent through that layer), and an outer coating of a skin protectant.

[0291] Optional step (b) drying or partially drying the former impregnated with the coagulant

[0292] If the former is immersed in the coagulant, the former is dried or partially dried according to the following steps.

[0293] Step (i) immersing the former into the first elastomeric film-forming composition to produce a first layer of the elastomeric film-forming composition on the mold

[0294] The former is dipped into a composition for producing an elastomeric film, embodiments of which have been described in detail above. The first dipped film-forming composition ("first elastomeric film-forming composition") may contain an antimicrobial agent in some embodiments, or may be free of an antimicrobial agent and free of a skin protectant in other embodiments to form a barrier film layer, depending on the specific layer structure being produced.

[0295] The former is placed in the dip tank for a period of time (residence time) to ensure that the former is evenly coated, but not so long as to form a thicker coating than necessary.

[0296] The temperature of the composition into which the former is immersed is generally in the range of 10° C. to 60° C. If the first film-forming composition contains any components that are heat sensitive, then the temperature may be varied or controlled within a narrower temperature range.

[0297] If a single film layer article is produced, then the next step performed is step (v).In embodiments where the elastomeric article comprises a barrier layer which is a barrier film layer, the first elastomeric film-forming composition is free of antimicrobial agents and free of probiotics and / or prebiotics.

[0298] Step (ii) drying or partially drying the first layer of the elastomeric film-forming composition on the former

[0299] In the case of applying a second (optionally, additional) film layer, the first layer is dried or partially dried before the next stage (impregnation stage). Conventional drying conditions known in the art are used when performing this step, such as those described in the previously mentioned PCT publication.

[0300] Step (iii) optionally immerses the former coated with the dried or partially dried first layer of the elastomeric film-forming composition into a second elastomeric film-forming composition to produce a second layer of the elastomeric film-forming composition on the former.

[0301] This step is optional and is present when producing a multi-layer film product. The temperature, residence time and total solid content of the elastomeric film-forming composition (i.e., the second elastomeric film-forming composition) used to produce the second layer of the glove can be the same as or different from those of the first dipping. The second elastomeric film-forming composition into which the former is dipped can be the same as or different from that of the first dipping.

[0302] In embodiments where the elastomeric article comprises a barrier film layer and the first elastomeric film-forming composition contains an antimicrobial agent, the second film-forming composition is free of an antimicrobial agent and free of probiotics and / or prebiotics in order to produce the barrier film layer.

[0303] In some embodiments, the second elastomeric film-forming composition contains a skin protectant. In these embodiments, the first elastomeric film-forming composition is free of antimicrobial agents and free of probiotics and / or prebiotics.

[0304] Step (iv) Optionally, repeat the drying or partial drying step (ii) and further perform the impregnation step (iii)

[0305] This step is optional and exists when a multilayer film product is produced. In a multilayer film product, the number of film layers can be 2, 3 or more. In each subsequent dipping stage, a film-forming composition is selected to produce the desired suitable layered structure. Therefore, in one embodiment, a third elastomer film-forming composition is used to produce a third elastomer film layer. The third elastomer film-forming composition can be a composition containing a skin protectant to produce a film layer containing a skin protectant. In such cases, the skin protectant is preferably heat-stable. If the skin protectant present in the film-forming composition is heat-stable, the dipping temperature should be appropriately controlled (e.g., by setting a maximum dipping temperature, such as 30°C). The choice of probiotics should also depend on its stability under the desired dipping conditions. In an alternative embodiment, the composition may be free of antimicrobial agents and skin protectants in order to produce another standard film layer (or barrier film layer, if present). In this case, the skin protectant can be applied through a coating composition, as described below.

[0306] Step (v) Optional additional steps before curing

[0307] Other steps may be employed to fine tune the manufacture of the elastomeric film or article. Details of some optional steps that may be performed prior to curing are described in the PCT publications referenced above. In short, the film or article may be pre-leached to remove extractable components, and the coating material may be applied before / after optional beading / cuffing. Some optional steps that may be performed at this stage are described below under the headings (v-1) and (v-2).

[0308] Step (v-1) - Pre-leaching

[0309] In some embodiments, after the elastomeric film composition dipping step and before curing, a leaching step (described as pre-leaching) is performed. At this time, the elastomeric film on the former contains an antimicrobial agent, and in some embodiments, the skin protectant will be applied by a subsequent coating stage (before or after curing). In such embodiments, it is desirable to perform a leaching step to remove or wash off excess chemical residues. Excess antimicrobial agent can be one of the chemical residues that can be washed off. In the absence of a leaching step, the antimicrobial agent may contaminate the composition containing the skin protectant; if the skin protectant includes probiotics, the antimicrobial agent may inactivate the probiotics. It is desirable that the selected antimicrobial agent is an antimicrobial agent that cannot be leached from the elastomeric film layer during the leaching step, so that the antimicrobial agent will not be completely removed or washed from the film during the leaching step. The antimicrobial agents tested herein and many other examples described herein cannot be leached in the leaching step.

[0310] Step (v-2) - Application of coating composition

[0311] In an optional step, the coating composition can be applied to the elastomeric film on the former before the curing step. This coating application step will usually be performed after the pre-leaching step (v-1) described above. In addition or alternatively, the coating composition can be applied after the curing step (vi) described below or in an offline process.

[0312] The coating composition applied at this moment can comprise coating polymer or polymer emulsion, and this coating polymer or polymer emulsion provides slippery characteristic to help wear article (for example, gloves).The coating applied can be described as polymer coating.Whether chlorination is performed later, polymer coating can be applied.The concentration of polymer in coating composition can be in the scope of about 0.1% to about 5% (by weight) of coating composition, for example, about 0.5% to about 3% (by weight) of coating composition.If chlorination is to be performed, the concentration of polymer is usually at the lower end of the scope (for example, up to 1%).If there is no chlorination, the concentration of polymer is usually at the upper end of the scope (for example, higher than 1%).

[0313] During this stage, the coating composition can be formulated to include a skin protectant to provide both slip and skin protection properties on one surface (the inner surface) of the elastomeric article. Alternatively, a conventional polymer coating can be applied, and the skin protectant can be applied by another technique described herein. In these embodiments, the polymer coating can constitute a barrier layer (when present). The details of applying the skin protectant to the polymer coating (composition including the coating) after curing will be further described below.

[0314] Step (vi) solidifying the layered elastic film on the former

[0315] The curing step is performed before the article is peeled off from the former. This step generally involves curing conditions for curing the elastomeric film. The curing step is well known in the art, and suitable conditions for this step are described in the PCT publication mentioned above.

[0316] Step (vii) Post-curing step

[0317] After curing, but before the article is stripped from the former, additional steps may be performed. Such optional steps may include cooling (cooling the former in water), chlorination, post-leaching, application of coating materials, and additional drying steps.

[0318] Step (vii-1) Chlorination

[0319] Alternatively, the article may be subjected to chlorination after curing. This may be performed after cooling the former in water. Chlorination is a process that changes the surface properties of an elastomeric article. For example, gloves subjected to chlorination have improved wearing properties. Chlorination may be performed regardless of whether a polymer coating has been applied. Chlorination may be performed at a concentration range of 400-1000 ppm (e.g., about 600-1000 ppm). If a polymer coating has been applied, chlorination may be performed at a lower concentration (e.g., 400-600 ppm). If no polymer coating has been applied prior to curing, chlorination may be performed at a higher concentration (e.g., 600-1000 ppm).

[0320] Leaching after step (vii-2)

[0321] Alternatively, post leaching may be performed after curing. This may be done after the chlorination step (if chlorination is performed).

[0322] Step (vii-3) Post-curing application of coating composition

[0323] In some embodiments, the skin protectant is applied as part of the coating composition after curing and before the article is stripped from the former. Alternatively, the coating composition may contain a polymeric coating material. Additional details of this optional step are provided below. If the skin protectant is applied by a different technique (e.g., if it is present in the latex composition of the last film layer applied, or if the coating is applied in an off-line process), then this step may be omitted.

[0324] Step (vii-4) Drying

[0325] The article and the coating on the article, if present, may be dried in a final drying step prior to the stripping step. Drying may be performed at a temperature above ambient temperature and below 90°C (eg, about 50-60°C).

[0326] Step (vii-5) Partial stripping and application of coating composition

[0327] Alternatively, the article can be partially stripped from the former and then the antimicrobial agent can be applied as part of a coating composition to the partially stripped surface in an in-line process. For example, in an embodiment where the article is a glove, the glove can be partially stripped to the fingers. Then, a coating composition comprising the antimicrobial agent can be applied to the partially stripped surface, for example by spraying, and then the coating composition can be (completely or partially) dried.

[0328] Step (viii) Stripping

[0329] At the end of the forming process, the film or article is completely peeled from the former.

[0330] Step (ix) Post-stripping step

[0331] After stripping, the glove may be subjected to a post-stripping treatment, such as application of a coating composition in an off-line process (e.g., a tumbling process). This optional step is described in further detail below. If the coating composition is applied by tumbling at this stage, then it may not be necessary to apply the coating composition in one of the earlier stages.

[0332] Elastomeric articles (such as gloves) can be packaged to protect and / or preserve either or both of the antimicrobial agent and the skin protectant on the surface thereof. The packaging can be in pairs, or a large number of articles can be packaged together. The packaging can be a sealed package to prevent contact with the external environment of the package. The packaging can be a vacuum package.

[0333] Applying a coating composition comprising a skin protectant to an elastomeric film

[0334] A single or multi-layer film may be coated with a coating composition comprising a skin protectant (probiotics, prebiotics, or a combination thereof).

[0335] There are many different techniques that can be used to form a coating comprising a skin protectant on a film surface. Suitable techniques include in-line techniques such as dipping and spraying and off-line techniques such as tumbling.

[0336] In one example, the coating composition containing the skin protectant is applied by a dipping process. This technique involves dipping the elastomeric film on the former into a coating composition containing the skin protectant. The coating composition can then be dried while the elastomeric article is on the former, after which the article is peeled off from the former. In the case of a dipping process or dip coating, the step of applying the coating composition containing the skin protectant after the elastomeric film layer is formed on the former can be performed at any suitable time in the article manufacturing process. In one example, it is appropriately applied after curing the elastomeric film but before peeling the cured film from the former. In such cases, the coating can be applied after curing and chlorination. The coating can be applied after the post-leaching step. The article can then be dried to dry the applied coating before peeling from the former. In another alternative, the step of applying the coating composition containing the skin protectant can be performed after forming the elastomeric film layer (after dipping, and after any pre-leaching treatment of the wet gel film) and before curing. In these embodiments, the coating composition preferably does not contain heat-sensitive probiotics, as they are generally incompatible with typical curing temperatures.

[0337] In another example, the coating composition comprising a skin protectant is applied by spraying. This technique involves spraying a coating composition comprising a skin protectant onto an elastomeric film on a former. The former may be rotated during spraying to ensure that the coating composition is evenly applied to each film or article. The coating composition may then be dried while the elastomeric article is on the former, after which the article is peeled off from the former. In the case of spraying, the time to perform this step is also suitable after curing the elastomeric film of the elastomeric article. However, the spraying step may be performed after the film is formed but before curing. In this case, the film may be an impregnated elastomeric film, or it may be an extruded elastomeric product. In this case, the coating composition comprising a skin protectant may be sprayed onto the extruded elastomeric article.

[0338] Alternatively, the coating composition containing the skin protectant may be applied by tumbling (with or without spraying). This technique involves preparing the article by dipping, extrusion or other methods, peeling the article from the former (if prepared by dipping), and then tumbling the article with the coating composition containing the skin protectant in a tumbling process. The coating composition may be applied in a drum dryer via a pump sprayer, or by adding the liquid coating composition to the dryer using another technique. In the case of spraying, the article is tumbled while spraying to ensure that the coating composition is evenly applied to each glove. The volume of the coating composition applied may typically be 1000 g per 500 cm 2 The range of about 1.5 mL or more of the article. Drying in a tumble dryer causes the solvent component of the coating composition to evaporate, leaving the skin protectant (and any other non-volatile components) on the surface of the elastomeric article. After all of the coating composition has been applied, drying is continued in a tumble dryer for a period of at least 5 minutes (e.g., 10 to 120 minutes, preferably 15 to 60 minutes) at a temperature above ambient temperature (e.g., above 35° C., preferably 40 to 70° C.). Preferably, the skin contacting surface of the article faces outward during the tumbling process to apply the coating to the exposed surface. The article can then be turned over again.

[0339] The coating composition may comprise:

[0340] - Skin protectants, and

[0341] - a solvent, preferably water.

[0342] The coating composition preferably comprises:

[0343] - Skin protectant,

[0344] - optionally, one or more of a dispersant, an emulsifier, a solubilizer, a rheology modifier, a wetting agent, an emollient, a skin conditioner, a moisturizer, a biocide, a preservative, a silicone, a fragrance, and a pH adjuster; and

[0345] -water.

[0346] If the skin protectant is applied as part of a polymeric coating composition, the coating composition preferably comprises:

[0347] - a skin protectant, preferably a heat-stable skin protectant, selected from probiotics, prebiotics or a combination thereof;

[0348] - coating polymer (described in further detail below);

[0349] - optionally, one or more of a dispersant, an emulsifier, a solubilizer, a rheology modifier, a wetting agent, an emollient, a skin conditioner, a moisturizer, a biocide, a preservative, a silicone, a fragrance, and a pH adjuster; and

[0350] -water.

[0351] The coating composition may contain a skin protectant in an amount of at least about 0.0005% or at least about 0.001% by weight of the coating composition. The amount may be at least 0.01%, 0.05%, 0.1%, 0.2%, 0.5%, 0.8%, 1.0% or 5% by weight of the coating composition. The amount may be at most 50%, 40%, 35%, 30%, 25%, 20%, 18%, 15%, 12%, 10% or 8% by weight of the coating composition. Any minimum and maximum amounts may be combined to form a range, such as between 0.5% and 20% by weight of the coating composition.

[0352] In some alternative embodiments, the coating composition may comprise a coating polymer and may be described as a polymer coating composition. As described above, if the skin protectant is applied as part of the polymer coating composition, it may be applied prior to curing (see step (v-2)) or after curing (and after post-leaching treatment; see step (vii-3)). If applied prior to curing, the coating composition preferably does not contain heat-sensitive probiotics, as they are generally incompatible with typical curing temperatures. If applied after curing, the temperature of any drying step prior to stripping needs to be set to ensure compatibility with any heat-sensitive probiotics present, or the skin protectant should be selected to be compatible with the drying conditions applied.

[0353] The formulation of the polymer coating composition may correspond to formulations known in the art for producing inner coatings on gloves to enhance donning properties, with the addition of a skin protectant. Such coating compositions contain a coating polymer.

[0354] The coating polymer is a polymer that provides a coating on the surface of the elastomeric film. The coating polymer may be selected from polyacrylic emulsions, polyurethane emulsions, silicone emulsions, paraffin waxes, polyethylene waxes or combinations thereof. The amount of the coating polymer in the coating composition may be a minimum of 0.01% and a maximum of 20% by weight of the polymer composition. The coating polymer preferably accounts for up to 5% of the coating composition by weight; if a polymer coating is to be applied and chlorination treatment is performed, then it is preferably up to 1% of the coating composition by weight. The minimum amount is preferably at least 0.1% by weight of the coating composition, preferably 0.5%. Any commonly used component in the polymer coating used for glove manufacturing may be included in the coating composition in typical amounts. These components may include dispersants, rheology modifiers, wetting agents, biocides and / or pH adjusters. The balance is usually water. The rheology modifier may be present in an amount of 0-5% (e.g., 0.01-2%) by weight, and the wetting agent may be present in an amount in the same range. The pH adjuster may be an agent for increasing or decreasing the pH of the composition, and may be an acid or a base. The target pH of the coating composition should be between 4.0 and 8.0, preferably between 5.0 and 6.0. If the pH conditions are outside this range, there is a risk of degradation of the beneficial skin flora. The pH conditions must also be suitable for the conditions used to manufacture the elastomeric film article, where pH is also an influencing factor.

[0355] If a polymer coating composition is applied, then the process can omit the chlorination treatment. Alternatively, a polymer coating can be applied and a chlorination treatment can be performed. In these embodiments, the concentration of the polymer in the coating composition, and the concentration of the chlorine used, are generally low. For example, the concentration of the polymer in the coating composition can be 0.5-3% by weight of the coating composition, and the concentration of chlorine can be 400-600 ppm.

[0356] The coating composition is preferably anhydrous gel. The final coating is also preferably a non-gelling coating. The coating composition is preferably free of alginates, such as sodium alginate.

[0357] The coating composition is suitably dried on the glove surface to obtain a dry surface. In some embodiments, the coating composition is dried to obtain a dry, dehydrated surface. The coating is suitably a dry, dehydrated coating.

[0358] Regarding the post-curing application of the coating composition containing the skin protectant, taking into account the possible presence of heat-sensitive probiotics, the coating conditions and drying conditions should be appropriately selected to maintain the stability of any heat-sensitive probiotics. The applicant has determined that the coating composition should be applied at a temperature below 50°C, preferably at a temperature of 25°C to 35°C. Although a temperature below 50°C is preferred, the coating composition or a film containing the coating composition is allowed to be subjected to higher temperature conditions (e.g., up to 60°C) for a short time. The duration of the high temperature condition (above 50°C, but preferably below 60°C) should be no more than 500 seconds or more preferably no more than 200 seconds. Maintaining the temperature condition at a temperature of no more than 50°C during the application of the coating composition is a feature of a preferred embodiment of the present invention. In some embodiments, the temperature will not rise to more than 60°C during any stage of the coating process. In some embodiments, the temperature condition may be no more than 48°C, no more than 46°C, no more than 44°C, no more than 42°C, or no more than 40°C.

[0359] After applying the coating composition, the coating can be dried in a final drying oven. The drying temperature can be above 60°C to no more than 130°C, however, in some embodiments, the drying temperature should be controlled at 40-60°C to avoid degradation of any heat-sensitive probiotics present. In the case of low-heat drying (i.e., drying at less than 60°C), a blower can be used to speed up the drying speed.

[0360] If the coating composition is applied before curing, the skin protectant should be selected from heat stable skin protectants such as thermophilic probiotics and thermostable prebiotics, considering that curing is usually performed in a curing oven at about 90°C or higher.

[0361] Applying a coating composition comprising an antimicrobial agent to an elastomeric film

[0362] Although the antimicrobial agent is preferably incorporated into the elastomeric film article by incorporation into the coagulant or into the elastomeric film-forming composition used to produce one of the film layers of the product, another alternative is to incorporate the antimicrobial agent by coating the elastomeric article with an antimicrobial coating composition. The coating composition should be applied to the surface of the film that will become the outer surface of the article.

[0363] The elastomeric article may be produced by an impregnation process via steps (i) to (ix) as described above, with or without the antimicrobial agent being incorporated into the coagulant or first impregnation layer; or the elastomeric article may be produced by any other process such as extrusion. The elastomeric article may be manufactured by another supplier, to which the antimicrobial coating composition is applied (wherein a coating composition comprising a skin protectant is applied to the opposite surface).

[0364] The antimicrobial agent may be applied to the elastomeric article by any suitable technique, such as tumbling, with or without spraying. The antimicrobial agent may be applied in an in-line process or an off-line process.

[0365] In one example, in an off-line process, the dried or partially dried elastomeric article is stripped from the former (step (viii) above) and then placed in a drum dryer. An antimicrobial coating composition comprising an antimicrobial agent is prepared. The coating composition typically comprises a solvent (such as water) to assist in applying the desired amount of antimicrobial agent to the article. The coating composition can be applied in the drum dryer via a pump sprayer or by adding a liquid coating composition to the dryer using another technique. In the case of spraying, the article is tumbled while spraying to ensure that the coating composition is evenly applied to each glove. The volume of the coating composition applied can typically be in the range of about 0.01 L or more, such as about 0.01 L to about 100 L. Drying in a drum dryer causes the solvent component of the coating composition to evaporate, thereby leaving the antimicrobial agent (and any other non-volatile components) on the surface of the elastomeric article. After all the coating composition has been applied, drying is continued in a tumble dryer for a period of at least 5 minutes (e.g., 10 to 120 minutes, preferably 15 to 60 minutes), typically at a temperature above ambient temperature (e.g., above 35° C., preferably 40 to 70° C.). Ensure that the outer surface of the article (i.e., the non-skin contact surface) faces outward during the tumbling process to apply the coating containing the antimicrobial agent to the exposed surface. If the article contains a skin protectant on its inner surface (i.e., the skin contact surface), slow tumbling (i.e., tumbling at a rotation frequency of no more than 60 revolutions per minute) can be used to reduce the possibility of the antimicrobial agent entering the inner surface of the article.

[0366] In another example, in an in-line process, a dried or partially dried elastomeric article is partially peeled from a former, and then the antimicrobial coating composition is sprayed on the partially peeled surface of the article. The antimicrobial coating is then allowed to dry (completely or partially) before the article is completely peeled from the former.

[0367] The coating composition can contain an antimicrobial agent, the amount of which (i.e., in the case of an antimicrobial agent combination, is a total amount) is at least about 0.0005% or at least about 0.001% by weight of the coating composition. This amount can be at least 0.01%, 0.05%, 0.1%, 0.2%, 0.5%, 0.8% or 1.0% by weight of the coating composition. This amount can be at most 50%, 40%, 35%, 30%, 25%, 20%, 18%, 15%, 12%, 10%, 8% or 5% by weight of the coating composition. Any minimum and maximum amounts can be combined to form a range, such as, between 0.5-20% or 0.5-10% by weight of the coating composition.

[0368] Description of options for producing articles

[0369] In the first table below, a number of the above options for producing the article are summarized to help understand the possible sequence of steps. Some options include off-line steps. The options outlined in methods 1 and 2 are preferred, as these are commercially viable and cost-effective options. In this table, the article is a glove, including a barrier layer that does not contain an antimicrobial agent or a skin protectant. The barrier layer can be a barrier film layer (which can contain a filler) or a coating.

[0370]

[0371]

[0372] Keywords: AM = antimicrobial agent; SPA = skin protectant

[0373] Notes to table:

[0374] a. If a skin protectant is added, it is a heat resistant skin protectant. If no skin protectant is added, the polymer coating may form a barrier coating.

[0375] b. If the antimicrobial agent is in the first latex dip, then this step can be performed to form a barrier film layer.

[0376] c. If a polymer coating is applied, it may be applied with or without chlorination. The polymer coating may contain a heat resistant skin protectant.

[0377] d. If there is no chlorination treatment after this step, the cooling treatment can be omitted.

[0378] e. If no polymer coating is applied, then chlorination is performed. If a polymer coating is applied, it can be applied with or without chlorination.

[0379] f. The antimicrobial agent is included in at least one of the coagulant or the first latex dipping composition, and may be included in both.

[0380] g. If there is no antimicrobial agent in the latex composition, then the latex layer can form a barrier film layer.

[0381] Figure 1 The diagram shows an elastomeric article containing a barrier layer, which can be prepared by the method described in the first table above. In particular, Figure 1 Possible arrangements of coatings and layers and possible locations of antimicrobial agents, skin protectants, and barrier layers within those coatings and layers are shown based on the order of steps performed. It should be noted that the layer labeled A1 is the coagulant layer. Although depicted as a different "layer," it should be understood that the coagulant layer is not retained in the final article as a different layer or coating, but is instead incorporated into (or merged into) the first layer of the film formed during the production of the elastomeric film. Thus, the antimicrobial agent present in the first elastomeric film layer will be present on the outer layer of the final elastomeric article. It should also be noted that the layer labeled C may include a polymer coating, a wear coating, or both. Although not shown in Figure 1 In the illustrated embodiment described, but alternatively, the polymer coating may be a barrier layer.

[0382] The second table below summarizes a number of options for producing articles, particularly gloves, that do not include a barrier layer. The options outlined in methods A and B are preferred as they are commercially viable and cost-effective options.

[0383]

[0384]

[0385] Keywords: AM = antimicrobial agent; SPA = skin protectant

[0386] Notes to table:

[0387] 1. If a polymer coating is applied, add a heat resistant skin protectant.

[0388] 2. If a polymer coating is applied, it can be applied with or without chlorination. The polymer coating may contain a heat resistant skin protectant.

[0389] 3. If there is no chlorination after this step, the cooling process can be omitted. If chlorination is performed, the cooling process is required.

[0390] 4. If a polymer coating is not applied, then perform a chlorination treatment. If a polymer coating is applied, then it can be applied with or without a chlorination treatment.

[0391] 5. The antimicrobial agent is included in at least one of the coagulant or the first latex dipping composition, and may be included in both.

[0392] Figure 2 The elastomeric article without a barrier layer is shown, which can be prepared by the method described in the second table above. In particular, Figure 2 Possible arrangements of coatings and layers and possible locations of antimicrobial agents and skin protectants within these coatings and layers are shown based on the order of steps performed.

[0393] Figure 3 An elastomeric article is shown having a barrier layer and an antimicrobial agent on the outer surface of the article (without any skin protectant on the inner surface).

[0394] Figure 4 A panel (10) prepared according to the test procedure for determining whether a surface of a film is "free of an antimicrobially effective amount of an antimicrobial agent". Figure 4 , a 1.6 cm diameter test film disk (20) is shown centered on a plate (10) coated with target bacteria. The growth of the target bacteria is inhibited in the region indicated by the shaded area (40), which extends between the edge of the disk (20) and the boundary (30) of the bacterial growth zone. Figure 4 The dashed line (50) shown indicates the 4 mm suppression distance region. Figure 4 In the test film, the inhibition distance region (between (20) and (30)) is greater than 4 mm, indicating that an antimicrobially effective amount of the antimicrobial agent is present on the test film disc (20).

[0395] definition

[0396] As used in this specification and the appended claims, the singular forms "a", "an", and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, "an antimicrobial agent" is meant to include one, two or more antimicrobial agents.

[0397] In the claims and foregoing description, unless the context requires otherwise by express language or necessary implication, the word "comprise" or variations such as "comprises" or "comprising" are used in an inclusive sense, i.e., specifically requiring the presence of the stated features, but not excluding the presence or addition of other features in various embodiments of the invention.

[0398] Example

[0399] The present invention will now be described in further detail with reference to the following non-limiting examples produced according to various embodiments of the invention.

[0400] Glove properties testing

[0401] The gloves were tested to determine the following properties:

[0402] ·Bactericidal effect (bacteria reduction %)

[0403] Modulus at 300%

[0404] Modulus at 500%

[0405] Tensile strength (MPa / Psi) (1MPa=145Psi)

[0406] % elongation; and

[0407] Breaking force (N).

[0408] Bactericidal efficacy can be measured according to the procedure specified in ASTM D7907 (Method A, Standard Test Method for Determining Bactericidal Efficacy on the Surface of Medical Examination Gloves). This standard is readily available. This test can be applied to multilayer films and elastomeric articles including gloves (such as examination gloves for medical use).

[0409] Tensile strength, stress at 300% and 500% modulus, and elongation at break are measured by a test procedure performed according to ASTM D412-16, based on sample sizes set by the glove standard. The breaking force of the gloves is also tested (measured according to EN 455). This standard is readily available. These tests can be applied to multilayer films and gloves (such as examination gloves for medical use). Tensile strength, modulus at 300% and modulus at 500% are all measured in MPa, and elongation (or elongation at break) is measured in %.

[0410] Multi-layer glove products containing antimicrobial agents in the outer layer

[0411] Example 1: Antimicrobial Agents in Elastomeric Film-Forming Compositions

[0412] Gloves were prepared using standard elastomeric film production techniques known in the art with the compositions listed below in Table 1.

[0413] Table 1 - Elastomeric film-forming composition for forming a first (outer) latex layer and a second (inner) latex layer

[0414]

[0415] The stages of glove production include:

[0416] 1. The glove-shaped former was dipped into a coagulant containing 13% calcium nitrate, 1.5% metal stearate (potassium stearate and / or calcium stearate), 0.1% wetting agent (nonionic alcohol ethoxylate) and no antimicrobial agent or skin protectant, and then dried.

[0417] 2. Dip the former into the first latex layer composition and partially dry the layer to a gel state. The samples produced contained different amounts of zinc pyrithione, including a control group (0 phr) and groups 1 (1 phr), 2 (2 phr), 3 (3 phr) and 4 (4 phr).

[0418] 3. Dip the former into the second latex layer composition and partially dry the layer to a gel state.

[0419] 4. Leaching (pre-leaching), involving immersion in an aqueous leachate.

[0420] 5. Cure the elastomeric film in an oven at 100 to 120°C for 20 minutes.

[0421] 6. Cool the former and film by immersing in room temperature water.

[0422] 7. Carry out chlorination at a chlorine concentration of 600-800 ppm.

[0423] 8. Glove rinsing / post-leaching.

[0424] 9. A coating composition having the formulation listed in Table 2 below was applied by dipping to produce a coating on the wearing surface of the glove.

[0425] 10. Dry in oven at 50°C-60°C for 5 minutes and then peel the gloves off the former.

[0426] Table 2 ——Prebiotic and probiotic coating composition

[0427] Element Percentage of composition (%) β-Glucan 0.02 Inulin 0.5 α-Glucan 0.5 Lactobacillus brevis extract 2 Emulsifier 5 Rheology Modifiers 0.5 Wetting Agents 0.1 water 91.38

[0428] The thickness of the finished glove (measured at the palm) was 0.08 mm ± 0.02 mm. The unaged and aged physical properties of the gloves were tested using ASTM D412 and EN455 methods, and the results are listed in Table 3 and Table 4, respectively. The aging results involve accelerated aging at 100°C for 22 hours.

[0429] Table 3——Physical properties of unaged gloves

[0430]

[0431]

[0432] Table 4 ——Physical properties of glove samples after accelerated aging

[0433]

[0434] All gloves passed the standard requirements of ASTM D6319 and EN 455. These results show that the physical properties of gloves prepared using zinc pyrithione in the elastomeric composition are as good as or even better than the control gloves, as shown. The tensile strength values ​​of the products range from 10 to 25 MPa, and the modulus values ​​at 500% range from 3 to 8 MPa; for both the control product and the exemplary product of the present invention, the elongation at break values ​​are in the range of 700-900%, and the breaking force values ​​are in the range of 6N to 10N.

[0435] The bactericidal activity of Group 3 gloves containing 3.0 phr zinc pyrithione was also tested compared to the control gloves. The results are shown in Table 5, which shows the percent bacterial reduction of the gloves (Group 3) prepared using 3.0 phr zinc pyrithione in the outer latex layer compared to the control gloves. The percentage was measured by the reduction in pathogen counts after contact with bacterial culture after 5, 10, 20, and 30 minutes of exposure. The results show that the presence of the antimicrobial agent zinc pyrithione in the outer layer of the gloves provides effective antimicrobial activity to the gloves.

[0436] Table 5 ——The bactericidal efficacy of gloves based on a time-kill study

[0437]

[0438] Example 2: Antimicrobial Agent Incorporated into Coagulant

[0439] A glove having a thickness of 0.08 mm + / - 0.02 mm was prepared using the same procedure and components as outlined in Example 1 (Steps 1 to 8) with the following changes:

[0440] - The coagulant composition also contained 2-phenylphenol in an amount of 3% (by weight) - The coagulant formulation had the composition listed below in Table 6. The control glove did not contain any 2-phenylphenol in the coagulant composition (i.e., the composition of Table 6 with 2-phenylphenol removed and the balance consisting of water).

[0441] - In both the gloves of Example 2 and the control, the first latex layer does not contain 2-phenylphenol.

[0442] Table 6 ——Coagulant composition containing 2-phenylphenol

[0443] Element Percentage of composition (%) Powder-free coagulant - metal stearate (potassium stearate and / or calcium stearate) 1.5 Wetting agent - alcohol ethoxylate (nonionic surfactant) 0.1 Calcium Nitrate 13 2-Phenylphenol 3 water 82.4

[0444] As with the gloves of Example 1, the gloves of Example 2 (including the control) contained the coating compositions listed in Table 2 on the inner (wearing) surface.

[0445] The finished gloves were tested for bactericidal activity. The results are shown in Table 7, which shows the percent bacterial reduction of the antimicrobial gloves containing 2-phenylphenol in the outer latex layer compared to the control gloves. The percentage was measured by the reduction in pathogenic bacteria count after contact with bacterial culture after 5, 10, 20 and 30 minutes of exposure. The results show that the presence of 2-phenylphenol antimicrobial agent in the coagulant composition used in the production of the gloves provides effective antimicrobial activity to the gloves compared to the control gloves without the antimicrobial agent.

[0446] Table 7 ——The bactericidal efficacy of gloves based on a time-kill study

[0447]

[0448] Single layer gloves

[0449] Example 3: Single-layer glove with coating on inner surface

[0450] This example was performed to test the efficacy of the skin protection coating on the wear side of a test glove in maintaining the skin microbiota compared to the efficacy of an antimicrobial on the surface of another test glove. It was assumed that the glove with the antimicrobial would be bactericidal, while the glove with the skin protection coating would not be bactericidal; this example sought to determine if this was in fact the case in the glove environment. Once determined, this would provide a baseline for evaluating whether the addition of an antimicrobial to the opposite side of a glove (as compared to the skin protection) would adversely affect the skin protection properties of that skin protection surface of the glove.

[0451] Two variants of single-layer gloves were prepared using the following steps:

[0452] 1. The glove-shaped former is dipped into a coagulant containing 13% calcium nitrate, 1.5% powder-free coagulant (metal stearate - potassium stearate and / or calcium stearate), 0.1% wetting agent, and no antimicrobial or skin protectant, and then dried.

[0453] 2. Dip the former into the "Second Latex Layer" composition listed in Table 1 to produce a single layer of film on the former, then partially dry the layer to a gel state.

[0454] 3. Leaching (pre-leaching), involving immersion in an aqueous leachate.

[0455] 4. The elastomeric film was cured in an oven at a temperature of 100 to 120°C for 20 minutes.

[0456] 5. Cool the former and film by immersing in room temperature water.

[0457] 6. Perform chlorination treatment (chlorine concentration is 600-800ppm).

[0458] 7. The coating compositions listed in Table 8 were applied by dipping to produce Group 1 and Group 2 gloves, respectively, having the coating on the wearing surface.

[0459] Table 8 ——Example 3 coating composition

[0460]

[0461] 8. Dry in a drying oven at a temperature of about 50°C-60°C for 5 minutes, and then peel the gloves from the former.

[0462] The finished gloves were tested for bactericidal activity. The test was performed by mixing the glove samples with the microbial strains in a reference medium. After 24 hours of incubation, the amount of residual substrate was determined. The results are shown in Table 9. The results show that the probiotic and prebiotic coatings selectively enhanced the growth of beneficial microbial flora, as shown. The results also show that the antimicrobial coating indiscriminately killed both beneficial and undesirable microbial flora, as shown.

[0463] Table 9 - Microbial activity of gloves with coatings containing prebiotics and probiotics, or coatings containing antimicrobial agents

[0464]

[0465] Example 4: Performance of different prebiotic and probiotic coatings

[0466] The latex compositions in Table 10 below were used to produce gloves containing antimicrobial agents.

[0467] Table 10 ——Latex composition for antimicrobial gloves

[0468]

[0469]

[0470] The gloves were produced according to the method described in Example 1. After the curing step and the post-leaching step, a prebiotic and probiotic coating was applied to the wearing surface of the glove, the composition of which is described in Table 11.

[0471]

[0472]

[0473] The efficacy of the prebiotic and probiotic coatings was tested according to the methods described below:

[0474] 1. To evaluate the efficacy of prebiotic and probiotic coatings using Lactobacillus casei strains.

[0475] 2. First prepare De Man, Rogosa and Sharpe (MRS) agar plates using MRS agar powder.

[0476] 3. Spread 100 μL of Lactobacillus casei strain dissolved in peptone water on MRS agar.

[0477] 4. Place 50 μL of 0.05% phenoxyethanol (a mild antimicrobial) in the center of the agar plate. This simulates the skin microbiota that is disrupted by antimicrobials.

[0478] 5. Cut the glove sample containing the prebiotic and probiotic coating into a diameter of 1.6 cm and then place it on top of the mild antimicrobial droplet. The surface coated with prebiotics and probiotics is in contact with the agar plate. This simulates the contact of the skin with the prebiotic and probiotic coating.

[0479] 6. Incubate the plate at 36°C for 48 hours.

[0480] 7. Measure the zone inhibition size after incubation. Measure the zone inhibition from the edge of the glove sample to the edge of the zone inhibition. Perform the measurement in three different areas and record the average of the three readings.

[0481] 8. The zone of inhibition size indicates the efficacy of the coating in promoting the growth of Lactobacillus casei cultured on agar plates. The smaller the zone of inhibition, the higher the efficacy of the prebiotic and probiotic coating.

[0482] 9. The results are shown in Table 12 below.

[0483] Table 12 -Zone inhibition size of gloves containing various prebiotic and probiotic coatings

[0484]

[0485]

[0486] Groups 4, 8 and 12 (all 2 mm inhibition zones) showed that Lactobacillus casei culture recovered better because the zone inhibition size was smaller than the control (6 mm). The prebiotic and probiotic coatings in groups 4, 8 and 12 promoted the growth of Lactobacillus casei. However, groups 17, 18 and 20 showed antimicrobial effects.

[0487] Example 5: Performance of different antimicrobial agents

[0488] Gloves containing different antimicrobial agents in the first latex layer were produced according to Table 13. The second latex layer was impregnated according to the composition described in Table 10.

[0489]

[0490]

[0491] Gloves were produced according to the method described in Example 1. The donning side of each set of gloves was coated with the prebiotic and probiotic coating composition described in Table 2.

[0492] The efficacy of antimicrobial agents added to latex compositions is evaluated using a zone inhibition test. The test method is as follows:

[0493] 1. Prepare Tryptic Soy Agar (TSA) plates by dissolving TSA agar powder in deionized water.

[0494] 2. Cultivation of Gram-positive cocci strains for use in the zone inhibition test A small amount of Gram-positive cocci cultured in an agar plate was taken out of the plate and then dissolved in peptone water.

[0495] 3. Take 100 μL of peptone water containing bacteria and spread it evenly on the agar plate. Place the glove sample with a diameter of 1.6 cm in the middle of the agar plate surface. The first latex layer is in contact with the agar plate.

[0496] 4. The plates were then incubated in an incubator at 36°C for 48 hours before measuring the zone of inhibition. The zone of inhibition is the area between the edge of the glove sample and the edge of the clear zone where there is no bacterial growth.

[0497] 5. Measure three locations and record the average size of the area.

[0498] 6. The size of the zone of inhibition indicates the efficacy of the antimicrobial agent. A large inhibition zone indicates good antimicrobial efficacy, while a small inhibition zone indicates weak antimicrobial efficacy. The results are shown in Table 14.

[0499] Table 14 -Zone inhibition size of gloves produced with different antimicrobial agents

[0500]

[0501]

[0502] Group 2 and Group 18 gloves showed better antimicrobial efficacy as the zones of inhibition were greater than the control.

[0503] Example 6: Coagulant and antimicrobial agent in the first latex layer

[0504] A powder-free coagulant solution containing an antimicrobial agent was prepared according to the coagulant composition described in Table 15 below.

[0505] Table 15 - Powder-free coagulant composition containing an antimicrobial agent

[0506]

[0507] Gloves containing an antimicrobial agent were prepared according to the latex composition described in Table 10, using 1 phr of zinc pyrithione instead of 1.5 phr. The gloves were produced using the dipping method described in Example 1. The prebiotic and probiotic coatings described in Table 2 were used to coat the wear side of the gloves after the post-leaching process. The control gloves contained an antimicrobial agent only in the first latex layer.

[0508] The efficacy of the antimicrobial agents added to the powder-free coagulant solution and the first latex layer composition was evaluated using the zone inhibition test in Table 16.

[0509] Table 16 -Zone inhibition size for gloves containing antimicrobial agents in both the coagulant layer and the first latex layer

[0510] Group Inhibition zone size (mm) Comparison 5 1 5 2 6 3 5 4 5

[0511] The addition of 0.2% phenoxyethanol in the coagulant layer enhanced the antimicrobial efficacy of the gloves as the zone inhibition size was slightly larger than the control.

[0512] Example 7: Antimicrobial Agents in Coagulant Layer

[0513] A powder-free coagulant solution containing an antimicrobial agent was prepared according to the coagulant composition described in Table 17 below.

[0514] Table 17 - Powder-free coagulant composition containing an antimicrobial agent

[0515]

[0516] Gloves were prepared according to Table 10 without zinc pyrithione in the first latex layer. The gloves were produced using the dipping method described in Example 1. The prebiotic and probiotic coating compositions described in Table 2 were used to coat the wear side of the gloves after the post-leaching process. The control gloves contained no antimicrobial agent.

[0517] The efficacy of the antimicrobial agents added to the powder-free coagulant solution was evaluated using the zone inhibition test in Table 18.

[0518] Table 18 — Size of the inhibition zone for gloves with an antimicrobial agent in the coagulant layer

[0519] Group Inhibition zone size (mm) Comparison 0 1 2 2 3 3 0 4 1

[0520] The mixture of phenoxyethanol, caprylyl glycol, and chlorphenesin in Group 2 showed good antimicrobial efficacy compared to zinc pyrithione.

[0521] Example 8: Antimicrobial Gloves with and without Barrier Layer

[0522] Antimicrobial gloves with and without a barrier layer were prepared according to the latex compositions described in Table 19. The gloves were produced using the dipping method described in Example 1. To determine the performance of the barrier layer in reducing migration of antimicrobial agents from the surface layer, neither prebiotics nor probiotics were coated on the wear side of the glove. No antimicrobial agent was added to the powder-free coagulant composition. The control gloves contained no antimicrobial agent.

[0523] Table 19 - Latex compositions for antimicrobial gloves with and without barrier layers

[0524]

[0525] The performance of the barrier layer in reducing the migration of the antimicrobial agent from the outer surface to the wear surface was evaluated using a zone inhibition test. The test method is described in Example 5. Both the outer surface (coagulant side) and the inner surface (wearing side) were evaluated and the results are shown in Table 20.

[0526] Table 20 -Zone inhibition size of gloves with and without barrier layer

[0527]

[0528]

[0529] The barrier layer greatly reduces or prevents the migration of the antimicrobial agent from the outer surface to the wear side. Large zones of inhibition were observed in both Group 1 and Group 2. Migration of the antimicrobial agent was evident in Group 2, which had a second latex layer without a lamellar filler. When a barrier layer had been established with a high lamellar filler (aluminum silicate and talc) as the second latex layer, the zone of inhibition was reduced.

[0530] Example 9: Antimicrobial gloves made with different elastomers

[0531] Antimicrobial gloves made of different elastomers were prepared using the latex compositions described in Table 21. The first latex layer was impregnated with the latex composition containing the antimicrobial agent. The second latex layer was impregnated with the same latex composition, but without the antimicrobial agent. The gloves were produced using the dipping method described in Example 1. The prebiotic and probiotic coating compositions described in Table 2 were used to coat on the wear side of the gloves after the post-leaching process. No antimicrobial agent was added to the coagulant composition.

[0532] Table 21 - Latex compositions for antimicrobial gloves made from different elastomers

[0533]

[0534]

[0535] The efficacy of antimicrobial gloves made with different elastomers was evaluated according to the method described in Example 5. For antimicrobial efficacy, the coagulant side was used as the surface in contact with the TSA agar plate. The performance of the prebiotic and probiotic coatings was evaluated using the method described in Example 4. For the prebiotic and probiotic coatings, the wearing surface was used as the surface in contact with the MRS agar plate.

[0536] Table 22 - Area inhibition size of gloves made of different elastomers

[0537]

[0538] Antimicrobial agents can be added to different elastomers to form elastomeric articles with antimicrobial properties. Less zone inhibition was observed in the natural rubber samples (Groups 3 and 4), which suggests that more antimicrobial agents are required for natural rubber latex because of its less antimicrobial efficacy compared to other types of elastomers.

[0539] Example 10: Antimicrobial efficacy before and after accelerated aging

[0540] The gloves produced in Example 1 were aged at 100° C. for 22 hours. The antimicrobial efficacy of the aged gloves was tested using the zone inhibition method described in Example 5.

[0541] Table 23 -Zone inhibition size for both unaged and aged antimicrobial gloves

[0542]

[0543] After accelerated aging, the antimicrobial efficacy of the antimicrobial gloves decreased slightly. This may be due to the thermal instability of zinc pyrithione. However, the retained antimicrobial efficacy is still significant and much higher than the control.

[0544] Example 11: Prebiotic and Probiotic Efficacy after Aging

[0545] Prebiotic / probiotic coated gloves were selected from Example 4 and further aged at 70°C for 7 days. The Zone Inhibition Test Method described in Example 4 was used to determine the skin protectant efficacy.

[0546] Table 23

[0547]

[0548] The growth of L. casei was inhibited within a 5 mm zone of the control glove, however, the size of the inhibition zone was smaller, demonstrating that the extent of growth inhibition was less (ie, improved compared to the control).

[0549] Example 12: Physical Properties of Antimicrobial Gloves

[0550] The physical properties of some antimicrobial gloves of the present invention were compared after accelerated aging.Accelerated aging was performed at 100°C for 22 hours.

[0551] - Glove A represents a control glove.

[0552] - Glove B has zinc pyrithione (1.5%) in the first latex layer and Ecodermine in the inner layer of the glove TM Antimicrobial gloves with a coating mixture of (2%) and Lactobacillus fermentation lysate (2%).

[0553] - Glove C represents glove B comprising a barrier layer in the second latex layer, the second latex layer consisting of layered aluminum silicate according to Example 8.

[0554] Table 24 ——Comparison of physical properties before and after aging

[0555]

[0556] These results show that despite the presence of antimicrobial and skin protectant and also lamellar filler (in the case of glove C), the glove quality is not significantly lower than the control containing neither antimicrobial nor skin protectant (nor lamellar filler).

[0557] Embodiment 13:

[0558] Antimicrobial efficacy of gloves containing zinc pyrithione (1.5%) in the first latex layer (glove exterior surface) and 4% lactobacillus fermentation lysate composition on the interior surface of the gloves, both against cultures of beneficial microorganisms (Lactobacillus casei) and against cultures of harmful microorganisms (Staphylococcus aureus). Lactobacillus casei and Staphylococcus aureus were cultured in MRS agar plates (method described in Example 4) and TSA agar plates (method described in Example 5) for glove samples with the exterior surface facing down and the interior surface facing down, respectively. After incubation at 36°C for 48 hours, the zone inhibition was measured. A glove of the same formulation but without the antimicrobial agent was used as a control (the exterior surface of the glove was placed on the plate with the exterior surface facing down).

[0559] Table 25 - Antimicrobial efficacy of zinc pyrithione and Lactobacillus fermentation lysate against beneficial and harmful bacteria

[0560]

[0561] The results demonstrate the efficacy of the outer antimicrobial surface of the glove against harmful bacteria (and beneficial bacteria). The inner surface of the glove was shown to support the growth of beneficial bacteria to a greater extent than that of harmful bacteria (with only minimal adverse effects on the growth of beneficial bacteria). The fact that each zone of inhibition was less than 4 mm indicates that the inner surface of the glove did not exhibit significant antimicrobial effects against both beneficial and harmful bacteria. If an effective amount of antimicrobial agent was present on the inner surface, then the zone of inhibition would be greater than 4 mm for both bacterial types.

[0562] entry:

[0563] 1A. An elastomeric article, comprising:

[0564] - an elastomeric film comprising one or more film layers and including an outer surface and an inner surface;

[0565] - an antimicrobial agent located on the outer surface of the elastomeric film; and

[0566] - A skin protectant selected from probiotics, prebiotics or a combination thereof, located on the inner surface of the elastomeric film.

[0567] 1B. An elastomeric article, comprising:

[0568] - an elastomeric film comprising one or more film layers and including an outer surface and an inner surface;

[0569] - an antimicrobial agent, which is effective against both beneficial and harmful microorganisms, located on the outer surface of the elastomeric film; and

[0570] - a skin protectant selected from probiotics, prebiotics or a combination thereof, located on the inner surface of the elastomeric film;

[0571] The inner surface of the film does not contain an antimicrobially effective amount of an antimicrobial agent that is effective against both beneficial and harmful microorganisms.

[0572] 1C. An elastomeric article, comprising:

[0573] - an elastomeric film comprising one or more film layers and including an outer surface and an inner surface;

[0574] - an antimicrobial agent located on the outer surface of the elastomeric film; and

[0575] - a skin protectant selected from probiotics, prebiotics or a combination thereof, located on the inner surface of the elastomeric film;

[0576] The film has the following characteristics:

[0577] - A modulus of less than 15 MPa at 500% elongation;

[0578] - A modulus of less than 10 MPa at 300% elongation;

[0579] - a tensile strength of at least 8 MPa; and / or

[0580] - The elongation at break is at least 200%.

[0581] 1D. An elastomeric article, comprising:

[0582] - an elastomeric film comprising one or more film layers and including an outer surface and an inner surface;

[0583] - an antimicrobial agent located on the outer surface of the elastomeric film; and

[0584] - A skin protectant selected from probiotics, isolated prebiotics or a combination thereof, located on the inner surface of the elastomeric film.

[0585] 2. The elastomeric article according to item 1, further comprising a barrier layer which isolates the antimicrobial agent and the skin protectant.

[0586] 3. The elastomeric article according to item 2, wherein the barrier layer is a barrier film layer or a barrier coating.

[0587] 4. The elastomeric article according to any one of items 1 to 3, wherein the elastomeric film is a single-layer film.

[0588] 5. The elastomeric article according to any one of items 1 to 3, wherein the elastomeric film is a multilayer film comprising a first film layer defining an outer surface of the article and a second film layer defining an inner surface of the article.

[0589] 6. The elastomeric article according to item 5, wherein the antimicrobial agent is present in the first film layer.

[0590] 7. The elastomeric article according to item 6, wherein the antimicrobial agent is present in the first film layer by incorporation into the coagulant used to produce the elastomeric article, or by incorporation into the elastomeric film-forming composition used to produce the first film layer.

[0591] 8. The elastomeric article according to item 7, wherein the amount of antimicrobial agent in the first film layer is from 0.01 to 20 phr.

[0592] 9. The elastomeric article according to any one of items 1 to 7, wherein the article comprises a coating on an outer surface of the article, the coating on the outer surface comprising an antimicrobial agent.

[0593] 10. The elastomeric article according to any one of items 1 to 9, wherein the skin protectant is present in a coating on the inner surface of the elastomeric film.

[0594] 11. The elastomeric article according to any one of items 1 to 10, wherein the article comprises a coating on an inner surface of the article, and the coating on the inner surface comprises a skin protectant.

[0595] 12. The elastomeric article according to item 11, wherein the coating comprises from about 0.001% to about 30% by weight of the total weight of the article.

[0596] 13. Elastomeric article according to item 11 or 12, wherein the total amount of skin protectant in the coating is at least 5% by weight of the coating.

[0597] 14. The elastomeric article according to any one of items 1 to 13, wherein the antimicrobial agent is selected from the group consisting of pyrithione, phenolic compounds, heterocyclic compounds, quaternary ammonium salts, biguanide compounds, parabens, antibiotics, antiviral agents, antifungal agents, antimicrobial peptides and combinations of one or more thereof.

[0598] 15. The elastomeric article according to item 14, wherein the antimicrobial agent is selected from the group consisting of pyrithione, phenolic compounds and combinations thereof.

[0599] 16. The elastomeric article according to any one of items 1 to 15, wherein the skin protectant comprises a probiotic selected from the group consisting of Lactobacillus, Lactococcus, Bifidobacterium and combinations thereof.

[0600] 17. The elastomeric article according to any one of items 1 to 16, wherein the skin protectant comprises a prebiotic selected from the group consisting of sugars, phytosphingosine and its derivatives or salts, lactic acid, glycomacropeptides, amino acids, peptides and combinations thereof.

[0601] 18. The elastomeric preparation according to item 17, wherein the prebiotic comprises a sugar selected from the group consisting of α-glucan, β-glucan, fructooligosaccharide, inulin and combinations thereof.

[0602] 19. The elastomeric article according to any one of items 1 to 18, wherein the elastomeric film comprises an elastomer selected from the group consisting of natural rubber, nitrile rubber, silicone rubber, polyvinyl chloride, polyethylene, polypropylene, polyurethane, polyisoprene, polychloroprene, polystyrene, acrylic polymers, polybutadiene, fluoroelastomers, copolymers or blends of these polymers or monomers thereof, and derivatives or blends thereof.

[0603] 20. The elastomeric article according to any one of items 1 to 19, wherein the elastomeric film comprises an elastomer selected from the group consisting of natural rubber, nitrile rubber, polyisoprene, polychloroprene, polyurethane, copolymers or blends of these polymers or monomers thereof, and derivatives or blends thereof.

[0604] 21. The elastomeric article according to any one of items 1 to 20, which is in the form of a glove, a cot or a footwear.

[0605] 22. The elastomeric article according to any one of items 1 to 21, wherein the average thickness of the article is between 0.01 and 3.0 mm.

[0606] 23. The elastomeric article according to any one of items 1 to 22, which has the following properties:

[0607] - modulus less than 15 MPa at 500% stretch,

[0608] - modulus less than 10 MPa at 300% stretch,

[0609] - a tensile strength of at least 8 MPa; and / or

[0610] - The elongation at break is at least 200%.

[0611] 24A. A method for manufacturing an elastomeric article, the method comprising the steps of:

[0612] - providing an elastomeric film comprising one or more film layers, the elastomeric film comprising first and second opposing surfaces;

[0613] - introducing an antimicrobial agent onto or into the first opposing surface; and

[0614] - Introducing a skin protectant selected from probiotics, prebiotics or a combination thereof onto or in the second opposing surface.

[0615] 24B. A method for manufacturing an elastomeric article, the method comprising the steps of:

[0616] - providing an elastomeric film comprising one or more film layers, the elastomeric film comprising first and second opposing surfaces;

[0617] - introducing an antimicrobial agent onto or into the first opposing surface in a manner that avoids introducing the antimicrobial agent onto or into the second opposing surface, the antimicrobial agent being effective against both beneficial and harmful microorganisms; and

[0618] - Introducing a skin protectant selected from probiotics, prebiotics or a combination thereof onto or in the second opposing surface.

[0619] 24C. A method for manufacturing an elastomeric article, the method comprising the steps of:

[0620] - providing an elastomeric film comprising one or more film layers, the elastomeric film comprising first and second opposing surfaces;

[0621] - introducing an antimicrobial agent onto or into the first opposing surface; and

[0622] - introducing a skin protectant selected from probiotics, prebiotics or a combination thereof onto or into the second opposing surface,

[0623] The method further includes preparing a film having an antimicrobial agent and a skin protectant while maintaining the following film properties:

[0624] - A modulus of less than 15 MPa at 500% elongation;

[0625] - A modulus of less than 10 MPa at 300% elongation;

[0626] - a tensile strength of at least 8 MPa; and / or

[0627] - The elongation at break is at least 200%.

[0628] 24D. A method for manufacturing an elastomeric article, the method comprising the steps of:

[0629] - providing an elastomeric film comprising one or more film layers, the elastomeric film comprising first and second opposing surfaces;

[0630] - introducing an antimicrobial agent onto or into the first opposing surface; and

[0631] - introducing a skin protectant selected from probiotics, isolated prebiotics or combinations thereof onto or in the second opposing surface.

[0632] 25. The method according to item 24, comprising the step of incorporating a barrier layer which separates the antimicrobial agent from the skin protectant.

[0633] 26. The method according to item 25, comprising the step of incorporating the barrier layer into an elastomeric article as a barrier film layer or a barrier coating.

[0634] 27. The method according to item 26, comprising the steps of: producing a first film layer from a first elastomeric film-forming composition comprising an antimicrobial agent to introduce the antimicrobial agent into a first opposing surface of the article; and, producing a barrier film layer as a separate layer of the elastomeric film.

[0635] 28. The method according to item 27, comprising the steps of: dipping the mold into a first elastomeric film-forming composition to produce a first film layer; and dipping the mold into a second elastomeric film-forming composition to form a barrier film layer.

[0636] 29. The method according to item 27 or 28, comprising the step of incorporating an antimicrobial agent into the first elastomeric film-forming composition in an amount ranging from 0.01 to 20 phr.

[0637] 30. The method according to item 26, comprising the steps of:

[0638] - dipping the mould into a coagulant composition comprising an antimicrobial agent, and then dipping the coagulant-impregnated mould into a first elastomeric film-forming composition to produce a first film layer of an elastomeric film, whereby the antimicrobial agent is incorporated into the first film layer by the dipping step; and

[0639] - Dipping the mold with the first film layer into the second elastomeric film-forming composition to form the barrier film layer.

[0640] 31. The method according to item 30, comprising the step of incorporating an antimicrobial agent into the coagulant composition in an amount of about 0.01% to about 50% by weight of the coagulant composition.

[0641] 32. The method according to any one of items 24 to 31, comprising the step of applying a coating composition comprising an antimicrobial agent onto the first opposing surface of the elastomeric film.

[0642] 33. The method according to item 32, comprising the step of spraying or rolling the coating composition onto the first opposing surface of the elastomeric film.

[0643] 34. The method according to any one of items 24 to 33, comprising the step of applying a coating composition comprising a skin protectant onto the second opposing surface of the elastomeric film.

[0644] 35. The method according to item 34, comprising the step of applying a coating composition comprising a skin protectant onto the second opposing surface of the elastomeric film in an amount of about 0.01% to about 50% by weight of the coating composition.

[0645] 36. The method according to item 34, comprising the step of applying a coating composition comprising a skin protectant onto the second opposing surface of the elastomeric film in an amount of about 0.01% to about 30% by weight of the coating composition.

[0646] 37. The method according to item 35 or 36, comprising the step of dipping, spraying or rolling the coating composition onto the second opposing surface of the elastomeric film.

[0647] 38. The method according to any one of items 34 to 37, wherein the coating composition applied to the second opposing surface of the elastomeric film comprises:

[0648] - 0.01-20% by weight of skin protectants;

[0649] - optionally, one or more of a dispersant, an emulsifier, a solubilizer, a rheology modifier, a wetting agent, an emollient, a skin conditioner, a moisturizer, a biocide, a preservative, a silicone, a fragrance, and a pH adjuster; and

[0650] -water.

[0651] 39. The method according to any one of items 34 to 38, comprising the step of applying a coating composition comprising a skin protectant to the elastomeric film by dipping or spraying in an in-line process before curing the elastomeric film.

[0652] 40. The method according to any one of items 28 to 31, comprising the step of dipping the mould having the first elastomeric film layer and the barrier layer into a third elastomeric film-forming composition comprising a skin protectant to produce a third film layer comprising a skin protectant, wherein the first elastomeric film layer comprises an antimicrobial agent.

[0653] 41. The method according to item 40, wherein the step of dipping the mold into a third elastomeric film-forming composition comprises dipping into a third elastomeric film-forming composition comprising 0.01-50 phr of a skin protectant.

[0654] 42. The method according to item 24, comprising the steps of: applying a coating composition comprising an antimicrobial agent to a first surface of the elastomeric film; and, applying a coating composition comprising a skin protectant to a second, opposing surface of the elastomeric film.

[0655] 43. An elastomeric article, comprising:

[0656] - an elastomeric film comprising one or more film layers and including an outer surface and an inner surface;

[0657] - an antimicrobial agent located on the outer surface of the elastomeric film;

[0658] - a skin protectant selected from probiotics, prebiotics or a combination thereof, located on the inner surface of the elastomeric film; and

[0659] - A barrier film layer that separates the antimicrobial agent from the skin protectant.

[0660] 44. A method for making an elastomeric article, the method comprising the steps of:

[0661] - providing an elastomeric film comprising one or more film layers, the elastomeric film comprising first and second opposing surfaces;

[0662] - introducing an antimicrobial agent onto or into the first opposing surface;

[0663] - introducing a skin protectant selected from probiotics, prebiotics or a combination thereof onto or into the second opposing surface; and

[0664] - A barrier film layer is provided in the elastomeric film layer, which barrier film layer separates the antimicrobial agent and the skin protectant.

[0665] 45. Elastomeric article produced by any one of items 24 to 42 and 44.

[0666] 46. ​​An elastomeric article, comprising:

[0667] - an elastomeric film comprising one or more film layers and including an outer surface and an inner surface;

[0668] - an antimicrobial agent, which is effective against both beneficial and harmful microorganisms, located on the outer surface of the elastomeric film; and

[0669] - A barrier film layer located between the antimicrobial agent on the outer surface and the inner surface of the elastomeric film to prevent the antimicrobial agent from contacting the skin contacting the inner surface of the article, wherein the inner surface of the film does not contain an antimicrobially effective amount of the antimicrobial agent that is effective against both beneficial and harmful microorganisms.

[0670] 47. An elastomeric article according to item 46, wherein the film layer comprises a first film layer and said barrier film layer, wherein the antimicrobial agent is present in said first film layer by incorporation into a coagulant used to produce the elastomeric article, or by incorporation into an elastomeric film-forming composition used to produce the first film layer.

[0671] 48. The elastomeric article according to item 46 or 47, which has the following characteristics:

[0672] - modulus less than 15 MPa at 500% stretch,

[0673] - modulus less than 10 MPa at 300% stretch,

[0674] - a tensile strength of at least 8 MPa; and / or

[0675] - The elongation at break is at least 200%.

[0676] 49. The elastomeric article according to any one of items 46 to 48, wherein the antimicrobial agent is selected from the group consisting of pyrithione, phenolic compounds, heterocyclic compounds, quaternary ammonium salts, biguanide compounds, parabens, antibiotics, antiviral agents, antifungal agents, antimicrobial peptides and combinations of one or more thereof.

[0677] 50. The elastomeric article according to any one of items 46 to 49, wherein the number of said film layers is two, comprising a first film layer comprising said antimicrobial agent and said barrier film layer, wherein the first film layer is located on one side of the barrier film layer and the polymer coating and / or donning coating is located on the opposite side of the barrier film layer.

Claims

1. An elastomeric article, comprising: - an elastomeric film comprising one or more film layers and including an outer surface and an inner surface; - an antimicrobial agent located on the outer surface of the elastomeric film, the antimicrobial agent being effective against both beneficial and harmful microorganisms; and - a skin protectant located on the inner surface of the elastomeric film, the skin protectant being selected from probiotics, prebiotics or a combination thereof; in, The inner surface of the film does not contain an antimicrobially effective amount of an antimicrobial agent effective against both beneficial and harmful microorganisms.

2. The elastomeric article of claim 1, further comprising a barrier layer separating the antimicrobial agent from the skin protectant.

3. The elastomeric article according to claim 2, wherein: The barrier layer is a barrier film layer or a barrier coating.

4. The elastomeric article according to any one of claims 1 to 3, wherein The elastomeric film is a single-layer film.

5. The elastomeric article according to any one of claims 1 to 3, wherein The elastomeric film is a multilayer film including a first film layer defining the outer surface of the article and a second film layer defining the inner surface of the article.

6. The elastomeric article according to claim 5, wherein: The antimicrobial agent is present in the first film layer.

7. The elastomeric article according to claim 6, wherein: The antimicrobial agent is present in the first film layer by incorporation into a coagulant used to produce the elastomeric article, or by incorporation into an elastomeric film-forming composition used to produce the first film layer.

8. The elastomeric article according to claim 7, wherein: The amount of the antimicrobial agent in the first film layer is from 0.01 to 20 phr.

9. The elastomeric article according to any one of claims 1 to 7, wherein The article comprises a coating on the outer surface of the article, the coating on the outer surface comprising the antimicrobial agent.

10. The elastomeric article according to any one of claims 1 to 9, wherein The skin protectant is present in a coating on the inner surface of the elastomeric film.

11. The elastomeric article according to any one of claims 1 to 10, wherein The article comprises a coating on the interior surface of the article, the coating on the interior surface comprising the skin protectant.

12. The elastomeric article according to claim 11, wherein The coating comprises from about 0.001% to about 30% by weight of the total weight of the article.

13. The elastomeric article according to claim 11 or 12, wherein: The total amount of the skin protectant in the coating is at least 5% by weight of the coating.

14. The elastomeric article according to any one of claims 1 to 13, wherein The antimicrobial agent is selected from the group consisting of hydroxypyrithione, phenolic compounds, heterocyclic compounds, quaternary ammonium salts, biguanide compounds, parabens, antibiotics, antiviral agents, antifungal agents, antimicrobial peptides, and a combination of one or more thereof.

15. The elastomeric article according to claim 14, wherein The antimicrobial agent is selected from the group consisting of hydroxypyrithione, phenolic compounds and combinations thereof.

16. The elastomeric article according to any one of claims 1 to 15, wherein The skin protectant comprises a probiotic selected from the group consisting of Lactobacillus, Lactococcus, Bifidobacterium and a combination thereof.

17. The elastomeric article according to any one of claims 1 to 16, wherein The skin protectant comprises a prebiotic selected from the group consisting of sugars, phytosphingosine and its derivatives or salts, lactic acid, glycomacropeptide, amino acids, peptides and combinations or salts thereof.

18. The elastomeric article according to claim 17, wherein The prebiotic comprises a sugar selected from the group consisting of α-glucan, β-glucan, oligofructose, inulin, and combinations thereof.

19. The elastomeric article according to any one of claims 1 to 18, wherein The elastomeric film comprises an elastomer selected from the group consisting of natural rubber, nitrile rubber, silicone rubber, polyvinyl chloride, polyethylene, polypropylene, polyurethane, polyisoprene, polychloroprene, polystyrene, acrylic polymers, polybutadiene, fluoroelastomers, copolymers or blends of these polymers or their monomers, and derivatives or blends thereof.

20. The elastomeric article according to any one of claims 1 to 19, wherein The elastomeric film comprises an elastomer selected from the group consisting of natural rubber, nitrile rubber, polyisoprene, polychloroprene, polyurethane, copolymers or blends of these polymers or their monomers, and derivatives or blends thereof.

21. The elastomeric article of any one of claims 1 to 20 in the form of a glove, a cot or a footwear.

22. The elastomeric article according to any one of claims 1 to 21, wherein The average thickness of the article is between 0.01 and 3.0 mm.

23. The elastomeric article according to any one of claims 1 to 22, having the following characteristics: - modulus less than 15 MPa at 500% stretch, - modulus less than 10 MPa at 300% stretch, - a tensile strength of at least 8 MPa; and / or - The elongation at break is at least 200%.

24. A method for making an elastomeric article, the method comprising: - providing an elastomeric film comprising one or more film layers, the elastomeric film comprising first and second opposing surfaces; - introducing the antimicrobial agent onto or into the first opposing surface in a manner that avoids introducing the antimicrobial agent effective against both beneficial and harmful microorganisms onto or into the second opposing surface; as well as - introducing a skin protectant selected from probiotics, prebiotics or a combination thereof onto or in said second opposing surface.

25. The method according to claim 24, comprising: A barrier layer is incorporated that separates the antimicrobial agent from the skin protectant.

26. The method according to claim 25, comprising the steps of: The barrier layer is incorporated into the elastomeric article as a barrier film layer or a barrier coating.

27. The method according to claim 26, comprising the steps of: producing a first film layer from a first elastomeric film-forming composition comprising the antimicrobial agent to introduce the antimicrobial agent into the first opposing surface of the article; and producing the barrier film layer as a separate layer of the elastomeric film.

28. The method according to claim 27, comprising the steps of: The mold is dipped into the first elastomeric film-forming composition to produce the first film layer, and then the mold is dipped into a second elastomeric film-forming composition to form the barrier film layer.

29. The method according to claim 27 or 28, comprising the steps of: The antimicrobial agent is incorporated into the first elastomeric film-forming composition in an amount of 0.01 to 20 phr.

30. The method of claim 26, comprising: - dipping the mould into a coagulant composition comprising the antimicrobial agent, and then dipping the mould impregnated with the coagulant into a first elastomeric film-forming composition to produce a first film layer of the elastomeric film, thereby incorporating the antimicrobial agent into the first film layer by the dipping step; as well as - dipping the mould having the first film layer into a second elastomeric film-forming composition to form the barrier film layer.

31. The method according to claim 30, comprising the steps of: The antimicrobial agent is incorporated into the coagulant composition in an amount of about 0.01% to about 50% by weight of the coagulant composition.

32. The method according to any one of claims 24 to 31, comprising the steps of: A coating composition comprising the antimicrobial agent is applied to the first opposing surface of the elastomeric film.

33. The method according to claim 32, comprising the steps of: The coating composition is sprayed or rolled onto the first opposing surface of the elastomeric film.

34. A method according to any one of claims 24 to 33, comprising the steps of: A coating composition comprising the skin protectant is applied to the second opposing surface of the elastomeric film.

35. The method according to claim 34, comprising the steps of: A coating composition comprising a skin protectant is applied to the second opposing surface of the elastomeric film in an amount of from about 0.01% to about 50% by weight of the coating composition.

36. The method according to claim 34, comprising the steps of: A coating composition comprising a skin protectant is applied to the second opposing surface of the elastomeric film in an amount of from about 0.01% to about 30% by weight of the coating composition.

37. The method according to claim 35 or 36, comprising: The coating composition is dipped, sprayed or rolled onto the second opposing surface of the elastomeric film.

38. A method according to any one of claims 34 to 37, wherein: The coating composition applied to the second opposing surface of the elastomeric film comprises: - 0.01-20% by weight of said skin protective agent; - optionally, one or more of a dispersant, an emulsifier, a solubilizer, a rheology modifier, a wetting agent, an emollient, a skin conditioner, a moisturizer, a biocide, a preservative, a silicone, a fragrance, and a pH adjuster; and -water.

39. A method according to any one of claims 34 to 38, comprising the steps of: The coating composition comprising the skin protectant is applied to the elastomeric film by dipping or spraying in an in-line process before curing the elastomeric film.

40. The method according to any one of claims 28 to 31, comprising the steps of: The mold having the first elastomeric film layer and the barrier layer is dipped into a third elastomeric film-forming composition comprising the skin protectant to produce a third film layer comprising the skin protectant, wherein the first elastomeric film layer comprises the antimicrobial agent.

41. The method of claim 40, wherein: The step of dipping the mold into the third elastomeric film-forming composition comprises dipping into a third elastomeric film-forming composition comprising 0.01 to 50 phr of a skin protectant.

42. The method according to claim 24, comprising the steps of: applying a coating composition comprising the antimicrobial agent to a first surface of the elastomeric film; and, applying a coating composition comprising the skin protectant to the second opposing surface of the elastomeric film.

43. An elastomeric article, comprising: - an elastomeric film comprising one or more film layers and including an outer surface and an inner surface; - an antimicrobial agent located on said outer surface of said elastomeric film, said antimicrobial agent being effective against both beneficial and harmful microorganisms; - a skin protectant located on the inner surface of the elastomeric film, the skin protectant being selected from a probiotic, a prebiotic or a combination thereof; and - a barrier film layer that separates the antimicrobial agent from the skin protectant; in, The inner surface of the film does not contain an antimicrobially effective amount of an antimicrobial agent effective against both beneficial and harmful microorganisms.

44. A method for making an elastomeric article, the method comprising the steps of: - providing an elastomeric film comprising one or more film layers, the elastomeric film comprising first and second opposing surfaces; - introducing the antimicrobial agent onto or into the first opposing surface in a manner that avoids introducing a microbial agent effective against both beneficial and harmful microorganisms onto or into the second opposing surface; - introducing a skin protectant selected from probiotics, prebiotics or a combination thereof onto or in said second opposing surface; as well as - providing a barrier film layer in the elastomeric film, the barrier film layer separating the antimicrobial agent and the skin protectant.

45. Elastomeric article produced by the method according to any one of claims 24 to 42 and 44.

46. ​​An elastomeric article, comprising: - an elastomeric film comprising one or more film layers and including an outer surface and an inner surface; - an antimicrobial agent located on the outer surface of the elastomeric film, the antimicrobial agent being effective against both beneficial and harmful microorganisms; and - a barrier film layer located between the antimicrobial agent on the outer surface of the elastomeric film and the inner surface to prevent the antimicrobial agent from contacting the skin contacting the inner surface of the article, wherein The inner surface of the film does not contain an antimicrobially effective amount of an antimicrobial agent effective against both beneficial and harmful microorganisms.

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