Medical pre-disinfection full-protection glove and preparation method thereof

Abstract

The application belongs to the technical field of medical devices, and discloses a medical pre-disinfection full-process protection glove and a preparation method thereof, wherein the body of the medical pre-disinfection full-process protection glove is prepared from an integrally formed latex outer layer and a medicine-soaked gauze inner lining layer; the medicine-soaked gauze inner lining layer is prepared by soaking medical gauze in ethanol-herbal sustained-release disinfection gel and then drying; the ethanol-herbal sustained-release disinfection gel has weak adhesion, and in the unused state, the upper surface and the lower surface of the latex glove body inside are bonded, the air in the latex glove body inside is exhausted, and at the same time, the opening of the latex glove body is closed to prevent the active ingredients from volatilizing and escaping. The application does not need to additionally disinfect the hands, and can provide active protection in the whole process when the medical staff uses it, has good protection effect, is convenient to use, has high cost performance, can be widely applied to scenes such as sampling of high-risk infectious viruses, field emergency medical aid, configuration of chemotherapy drugs and the like, and has wide application range.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a medical pre-sterilized full-process protective glove and its preparation method. Background Technology

[0002] Medical protective gloves are widely used in various medical activities. Common types include latex gloves, nitrile gloves, PVC gloves, and polyethylene gloves. Among them, latex gloves have good elasticity and sensitive touch, making them suitable for delicate operations (such as surgery and sample collection). However, they also have shortcomings such as low structural strength and lack of antibacterial and bacteriostatic functions, making them prone to damage during use. Their resistance to needle punctures, chemical penetration, and virus barrier properties are generally average, and they cannot simultaneously meet the requirements of liquid absorption, leakage prevention, and antibacterial properties. Therefore, traditional protective gloves mainly rely on the thin film layer as a physical barrier. If damaged or opened, it may lead to infection risks, and they must be used in conjunction with external disinfectants. When using traditional protective gloves, medical personnel must disinfect their hands separately before putting on the gloves, and also disinfect the protective gloves themselves. This is inconvenient, especially in scenarios requiring "zero penetration" and limited disinfection conditions, such as high-risk infectious virus sampling, emergency medical rescue in the field, and chemotherapy drug preparation. Multiple disinfection and thorough disinfection are often not possible, and the overall protective effect cannot meet the requirements of higher protection levels. They also cannot provide active protection throughout the entire process of medical personnel using the gloves.

[0003] To address these issues, some specially manufactured medical protective gloves have emerged in the existing technology. For example, CN106174814A discloses an antibacterial glove and its preparation method. In this method, the glove is pretreated in a pretreatment solution, then activated by immersing it in an activation solution, washed with pure water, then immersed in an antibacterial solution, washed again with pure water, then immersed in a crosslinking solution, grafted under ultraviolet light, washed with pure water, and finally immersed in the aforementioned antibacterial solution, washed with pure water, and dried at room temperature in a ventilated place to obtain the antibacterial glove. On the one hand, this method adds a new manufacturing process to the existing glove, making the overall process complex. Moreover, it only improves the antibacterial performance of the product and cannot improve the structural strength and overall protection level. Another type of sterile glove disclosed in KR20220077624A has a three-layer structure consisting of an inner glove, a disinfectant layer, and an outer glove. The manufacturing process is complicated, and the structural strength and protection level are insufficient. Another type of protective glove for chemotherapy disclosed in CN 113057736 A has four layers: an antibacterial coating, an outer layer (including a cavity), an inner layer, and a sweat-absorbing pad. The inner cavity of the outer layer is filled with disinfectant, and the inner side of the inner layer is fixedly connected to the sweat-absorbing pad. The structure is extremely complex and mainly relies on the antibacterial coating to provide external disinfection. When the glove is damaged, the disinfectant will flow out along the damaged area, rendering the glove unusable. The overall cost-effectiveness is low, and it cannot be promoted and applied on a large scale. Summary of the Invention

[0004] To address the shortcomings of existing technologies, the present invention aims to meet the diverse needs of medical activities conducted under severely limited conditions, such as high-risk infectious virus sampling and emergency medical rescue in the field, requiring disinfection-free operation, high structural strength, and continuous active protection. Building upon existing specialized medical protective gloves, this invention synergistically improves the product structure, formulation, and process by introducing an ethanol-herbal sustained-release disinfectant gel and a drug-impregnated gauze lining layer integrally molded with the latex layer. This significantly simplifies the product structure, formulation, and preparation process. Doctors no longer need to disinfect their hands or the gloves themselves before use. The high structural strength provides efficient active protection throughout the entire process for medical personnel. While meeting requirements for absorbency, leak prevention, antibacterial properties, and wearing comfort, the invention allows for the sustained release and sealing of the disinfectant active ingredients, achieving a high level of overall protection. It is particularly suitable for use in scenarios requiring "zero penetration" and limited disinfection conditions, such as high-risk infectious virus sampling, emergency medical rescue in the field, and chemotherapy drug preparation. Deep disinfection of the hands can be achieved quickly after wearing, and the overall cost is low, facilitating large-scale promotion and use, thus solving the aforementioned technical problems.

[0005] The technical solution provided by the present invention to achieve the above objectives is as follows: A medical pre-sterilized full-process protective glove includes a latex glove body, which is made of an integrally molded latex outer layer and a drug-impregnated gauze inner lining. The drug-impregnated gauze inner lining is made by soaking medical gauze in an ethanol-herbal sustained-release disinfectant gel and then drying it. The ethanol-herbal sustained-release disinfectant gel has weak adhesion. When not in use, the top and bottom of the latex glove body are bonded together, venting the air inside the latex glove body and sealing the opening of the latex glove body to prevent the active ingredients from evaporating and escaping. During use, the drug-impregnated gauze inner lining slowly releases the active ingredients in the ethanol-herbal sustained-release disinfectant gel, providing continuous active protection.

[0006] The ethanol-herbal sustained-release disinfectant gel is made from the following components in the indicated mass percentages: 70-75% ethanol, 1-2% carboxymethyl chitosan, 2-3% glycerol, 3-5% herbal compound extract, 0.1-0.2% hydrogen peroxide, 0.1-0.2% sodium alginate, 0.02-0.05% β-cyclodextrin-encapsulated baicalin, with the balance being deionized water. The herbal compound extract is made from the following components by weight percentage: Scutellaria baicalensis extract 8-10%, Lonicera japonica extract 5-8%, Clove extract 3-5%, Mentha haplocalyx extract 1-2%, and the remainder is deionized water.

[0007] The volume concentration of ethanol is 95%.

[0008] A method for preparing a medical pre-sterilized full-protection glove, characterized by comprising the following steps: S1: Preparation of ethanol-herbal sustained-release disinfectant gel First, a herbal compound extract was prepared, then a carboxymethyl chitosan gel was prepared. Then, at low temperature, the herbal compound extract, carboxymethyl chitosan gel, ethanol, glycerol, sodium alginate, β-cyclodextrin-encapsulated baicalin, and hydrogen peroxide were added to deionized water and homogenized. S2. Preparation of the drug-impregnated gauze lining layer The medical gauze is surface pretreated, then immersed in ethanol-herbal sustained-release disinfectant gel, vacuumed, removed and dried at low temperature, and cut into gauze patches that match the mold. S3, Dip molding The cut gauze patch is attached to the surface of the mold. The mold and the gauze patch are then immersed in a thin latex solution and quickly removed. The gauze patch and the thin latex solution together form a composite inner lining layer. Then, the mold is immersed in a high-solids latex solution and quickly removed to form a latex outer layer of appropriate thickness. S4, vulcanization crosslinking First, low-temperature drying and pre-vulcanization are carried out, followed by microwave vulcanization, so that the composite inner lining layer and the latex outer layer can be quickly cross-linked to complete the integral molding. S5, Post-processing The process involves rolling the edges, demolding, venting, quality inspection, sterilization, and finally sealing and packaging.

[0009] The medical pre-sterilized full-process protective gloves and their preparation method provided by this invention have at least the following beneficial effects compared with the prior art: 1. The protective gloves and preparation method provided by this invention address the needs for disinfection-free, high-strength, and continuous active protection during medical activities conducted under severely limited conditions, such as high-risk infectious virus sampling and emergency medical rescue in the field. Based on existing special medical protective gloves, this invention synergistically improves the product structure, formula, and process by introducing an ethanol-herbal sustained-release disinfectant gel and a drug-impregnated gauze lining layer integrally molded with the latex layer. This significantly simplifies the product structure, formula, and preparation process. Doctors do not need to disinfect their hands separately before use, nor do they need to disinfect the protective gloves themselves. After wearing, the gloves provide short-lasting protection. The gloves can achieve deep and thorough disinfection of hands in a short time (generally within 2-3 minutes) without the need for additional disinfectant. The protective gloves have a high structural strength and can provide efficient active protection for medical personnel throughout the entire process of use. While meeting the requirements of liquid absorption, seepage prevention, antibacterial properties, and wearing comfort, the overall protective effect can meet the requirements of a high level of protection. They are particularly suitable for use in scenarios that require "zero penetration" and have limited disinfection conditions, such as high-risk infectious virus sampling, emergency medical rescue in the field, and chemotherapy drug preparation. They are easy to store, carry, and use, and have low overall cost, making them easy to promote and use on a large scale.

[0010] 2. The ethanol-herbal sustained-release disinfectant gel used in this invention has good compatibility among its components and a high ethanol content. Under alkaline conditions, it is combined with active ingredients such as hydrogen peroxide, which provides stable sustained release, broad-spectrum, and rapid disinfection effects without irritating the skin. It can be specifically designed for high-risk virus / toxic environments and emergency rescue scenarios where disinfection conditions are limited. By employing sustained release and active protection, it slowly releases disinfectant active ingredients during use, ensuring that highly diffusive bacteria entering from the cuff are intercepted outside the glove's internal space or that bacteria entering the internal space are quickly killed. This can fill the gap in existing medical gloves in the field of high-risk virus protection.

[0011] 3. The product and preparation method provided by this invention mainly involve a combination of pre-preparation of ethanol-herbal sustained-release disinfectant gel, medicated gauze lining, step-by-step impregnation, low-temperature vulcanization, and post-treatment. This achieves stable bonding between the gauze and the ethanol-herbal sustained-release disinfectant gel, as well as a high loading of active ingredients. Furthermore, it improves the interfacial strength between the latex and gauze, ensuring a stable composite between the gauze lining and the outer latex layer. Simultaneously, it enhances the structural strength and active protection capabilities of the glove, enabling it to maintain structural integrity and internal sealing even under significant mechanical abrasion, tearing, or puncture. Finally, it minimizes the loss of effective ingredients in the ethanol-herbal sustained-release disinfectant gel, allowing for continuous sustained release within the sealed space inside the glove to maintain an effective disinfection concentration. Compared to traditional medical protective gloves and their manufacturing processes, the product of this invention offers three major advantages: active protection, environmental safety, and comfortable wear. It can replace traditional disinfectants, has a compact manufacturing process, is easy to scale up, and has controllable costs; the comprehensive cost per pair of gloves in mass production is less than 2.5 yuan.

[0012] 4. The medical protective gloves provided by this invention meet the requirements of Class II medical device standards. By introducing a gauze lining layer that adsorbs ethanol-herbal sustained-release disinfectant gel and controlling the overall thickness, it can ensure the convenience of medical personnel when collecting virus samples or handling other toxic substances. At the same time, it keeps the inside of the gloves at a high disinfection concentration and in a protective state throughout the process, protecting the hands of medical personnel from toxic substances completely and preventing bacteria from entering the human body through the opening or damaged parts of the gloves. The gauze lining layer carries the condensed medicine and also enhances the protective effect, preventing damage to the gauze adhesive layer.

[0013] 5. The medical protective gloves provided by this invention utilize an ethanol-herbal sustained-release disinfectant gel, primarily composed of ethanol and traditional Chinese medicine extracts. This gel is pre-soaked in the gauze lining of the gloves, then dried and stored in a dry, sealed environment. Medical personnel can wear the gloves directly in low-risk areas without prior hand disinfection. Thorough hand disinfection is achieved inside the gloves, maintaining a high disinfection concentration, before proceeding to high-risk areas for sampling, treatment, and other medical activities. During this process, any bacteria or viruses entering the gloves are eliminated. After use, medical personnel can remove the gloves upon returning to low-risk areas without further hand disinfection or other protective procedures. This significantly reduces the protective equipment required for medical personnel entering and exiting high-risk areas and simplifies the protective operation process.

[0014] 6. The medical protective gloves provided by this invention utilize an ethanol-herbal sustained-release disinfectant gel with a sustained-release, composite, enhanced bactericidal effect. This gel can effectively kill a variety of common pathogenic bacteria, viruses, and other microorganisms. Ethanol is the main disinfectant component, while the herbal extracts enhance the antibacterial effect. Carboxymethyl chitosan has sustained-release and weak viscosity properties, which prolongs the action time of the disinfectant components and makes it easy for gauze to adhere tightly to the mold surface to form the glove lining. Carboxymethyl chitosan, glycerin, and herbal extracts can all improve the moisturizing properties of the lining, improve the odor, and reduce the irritation of the lining to the skin.

[0015] 7. Through actual testing, the products and preparation processes provided by this invention have overcome the limitations of existing similar products and applications. They can be widely used in scenarios requiring "zero penetration," such as high-risk infectious virus sampling, emergency medical rescue in the field, and chemotherapy drug preparation. There is no need to carry other hand disinfection products. The application range is wide, the overall cost is low, and it is easy to promote and popularize them on a large scale and at low cost. Attached Figure Description

[0016] Figure 1 This is a schematic diagram of the external outline of the medical pre-sterilized full-process protective gloves prepared according to an embodiment of the present invention.

[0017] Figure 2 This is a schematic diagram of the planar unfolded structure of the medicated gauze lining layer in the medical pre-sterilized full-process protective gloves prepared according to an embodiment of the present invention.

[0018] Figure 3 A three-dimensional structural diagram of the medical pre-sterilized full-process protective gloves prepared according to an embodiment of the present invention; Figure 4 A three-dimensional structural diagram of the medical pre-sterilized full-process protective gloves prepared according to an embodiment of the present invention from another perspective; Figure 5 This is a schematic diagram illustrating the usage state of the medical pre-sterilized full-process protective gloves prepared according to an embodiment of the present invention. Detailed Implementation

[0019] To make the objectives, technical solutions, and advantages of this invention clearer, the technical solutions of this invention will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are only for explaining this invention and are not intended to limit this invention. Furthermore, the technical features involved in the various embodiments of this invention described below can be combined with each other as long as they do not conflict with each other.

[0020] Basic Implementation See Figures 1-2The medical pre-sterilized protective latex gloves provided in this embodiment are available in sizes XS, S, M, L, XL, and XXL. These gloves comprise a latex glove body 1, which is made of an integrally molded latex outer layer 2 and a medicated gauze inner lining layer 3. The medicated gauze inner lining layer 3 is made by soaking medical gauze in an ethanol-herbal slow-release disinfectant gel and then drying it. The ethanol-herbal slow-release disinfectant gel has weak adhesion; when not in use, it bonds the top and bottom of the latex glove body, expelling air from the inside and sealing the opening to prevent the active ingredients from evaporating. During use, the medicated gauze inner lining layer 3 slowly releases the active disinfectant components from the ethanol-herbal slow-release disinfectant gel, providing continuous active protection. This rapidly kills bacteria / viruses on the hands of medical personnel and also rapidly kills bacteria / viruses that enter the glove from the wrist, preventing contact between bacteria / viruses and human skin.

[0021] The medical gauze mentioned above is a hollow polyester / cotton composite gauze that has undergone plasma surface activation treatment. The specific type of gauze can be selected according to needs, with high-count, high-density combed cotton gauze being preferred.

[0022] In each embodiment, the specific selection of medical gauze can comprehensively consider design factors such as application scenarios (e.g., liquid absorption, seepage prevention, antibacterial properties), mechanical properties (strength, elasticity), and regulatory compliance (YY / T, USP, EN standards), while also taking into account absorbency, breathability, and strength. Surface modification (e.g., plasma treatment) can be used to improve the adsorption uniformity of the ethanol-herbal sustained-release disinfectant gel. In each embodiment of the present invention, hollow polyester / cotton composite yarn can be specifically selected. Hollow polyester / cotton composite yarn has a better synergistic effect with the ethanol-herbal sustained-release disinfectant gel, resulting in a larger adsorption capacity. It is suitable for scenarios requiring rapid adsorption and breathability, high humidity, or long-term operation, allowing the active ingredients adsorbed inside the gauze to maintain an effective sterilization concentration for an extended period.

[0023] Each glove's medicated gauze lining layer 3 includes an upper piece 31 and a lower piece 32 with a symmetrical structure. After being vulcanized with the latex outer layer 1, they correspond to form the upper and lower surfaces of the latex glove body 1, which have a weak adhesiveness.

[0024] The ethanol-herbal sustained-release disinfectant gel is made from the following components in the indicated mass percentages: 70-75% ethanol, 1-2% carboxymethyl chitosan, 2-3% glycerol, 3-5% herbal compound extract, 0.1-0.2% hydrogen peroxide, 0.1-0.2% sodium alginate, 0.02-0.05% β-cyclodextrin-encapsulated baicalin, with the balance being deionized water. The herbal compound extract is made from the following components by weight percentage: Scutellaria baicalensis extract 8-10%, Lonicera japonica extract 5-8%, Clove extract 3-5%, Mentha haplocalyx extract 1-2%, and the remainder is deionized water.

[0025] The volume concentration of ethanol is 95%.

[0026] A method for preparing a pre-sterilized, fully protective medical glove, comprising the following steps: S1: Preparation of ethanol-herbal sustained-release disinfectant gel First, a herbal compound extract is prepared, followed by a carboxymethyl chitosan gel. Then, at low temperature, the herbal compound extract, carboxymethyl chitosan gel, ethanol, glycerol, sodium alginate, β-cyclodextrin-encapsulated baicalin, and hydrogen peroxide are sequentially added to deionized water and homogenized. The specific steps include the following: S1-1: Preparation of raw materials Ethanol, carboxymethyl chitosan, glycerol, hydrogen peroxide, Scutellaria baicalensis extract, Lonicera japonica extract, Clove extract, Mentha haplocalyx extract, sodium alginate, β-cyclodextrin-encapsulated baicalin (baicalin-β-cyclodextrin inclusion complex), and deionized water were prepared separately. S1-2: Preparation of herbal compound extract Add the Scutellaria baicalensis extract, Lonicera japonica extract, Clove extract, and Mentha haplocalyx extract to the remaining deionized water and homogenize at 1500-2000 rpm for 5-10 min to obtain the herbal compound extract. S1-3: Preparation of carboxymethyl chitosan gel liquid Carboxymethyl chitosan was added to an appropriate amount of deionized water and stirred continuously until the carboxymethyl chitosan was completely dissolved. The pH value was adjusted to 6.0-7.0 to obtain a carboxymethyl chitosan gel solution. This preparation method can effectively improve the solubility of chitosan. In synergy with sodium alginate and β-cyclodextrin-encapsulated baicalin, it can improve the dispersion uniformity and sustained-release effect of active ingredients in the disinfectant gel formulation. Secondly, it can make the overall pH value of the final disinfectant gel less than 7 (the herbal compound extract is also alkaline), which is in an alkaline environment and improves the stability of hydrogen peroxide. S1-4: Preparation of ethanol-herbal sustained-release disinfectant gel Carboxymethyl chitosan gel, glycerol, herbal compound extract, sodium alginate, β-cyclodextrin-encapsulated baicalin, and ethanol were added to deionized water and homogenized at 1500-2000 rpm for 10-20 min. Finally, hydrogen peroxide was added and homogenized again at 1500-2000 rpm for 5-10 min to obtain ethanol-herbal sustained-release disinfectant gel, which was then allowed to stand at a low temperature not exceeding 15℃ for later use. S2. Preparation of the drug-impregnated gauze lining layer The medical gauze undergoes surface pretreatment, followed by immersion in an ethanol-herbal sustained-release disinfectant gel, vacuum sealing, low-temperature drying, and cutting into gauze patches that match the mold; specifically, the steps are as follows: S2-1: Pretreatment of medical gauze Plasma surface activation treatment is applied to medical gauze. Low-temperature plasma activates the fiber surface, introducing hydrophilic groups such as hydroxyl (-OH) to optimize the gauze porosity and balance adsorption capacity and air permeability. Specifically, plasma graft polymerization (PGP) can be used. First, plasma is used to activate the gauze fiber surface and introduce active groups. Then, new active branches are attached to the fiber surface through graft polymerization to form a new surface layer, thereby simultaneously improving the adsorption capacity and air permeability of disinfectant gel. S2-2: Vacuum impregnation The pretreated medical gauze was immersed in ethanol-herbal sustained-release disinfectant gel, and a vacuum was drawn to maintain a vacuum degree of -0.08MPa. The immersion time was 3-5 minutes to allow the disinfectant gel to fully penetrate into the fibers of the medical gauze. S2-3: Low-temperature drying Dry with hot air circulation at a temperature not exceeding 40℃ for 20-30 minutes to control the final moisture content to 5-8 wt%. S2-4: Symmetrical Cutting Cut the medical gauze into upper and lower pieces that match the shape and size of the glove mold and have a symmetrical structure. S3, Dip molding The cut gauze patch is attached to the mold surface, and the mold and gauze patch are immersed in a thin latex solution and quickly removed. The gauze patch and the thin latex solution together form a composite inner lining layer. Then, it is immersed in a high-solids content latex solution and quickly removed to form a latex outer layer of appropriate thickness. The specific steps include the following: S3-1: Gauze lining fit First, prepare a mold (usually made of ceramic or aluminum, shaped to match the hand) and clean it. Then, attach the pre-treated gauze lining, including the upper and lower pieces, directly to the upper and lower surfaces of the mold using its own weak adhesiveness. S3-2: First immersion The mold, along with the gauze lining, is immersed in a dilute latex solution with a solid content of 15-20 wt% for 5-10 seconds, allowing the dilute latex solution to fully penetrate the cotton yarns of the gauze lining and the gaps between the cotton yarns, forming a composite lining layer. S3-3: Second immersion Then immerse it in a latex solution with a solid content of 30-35 wt% for 10-15 seconds to form a latex outer layer with a thickness of 0.2-0.5 mm; The latex liquid and diluted latex liquid mentioned above are made by mixing natural latex and nitrile rubber in a mass ratio of 7:3, and then filtering, stabilizing and adding appropriate additives, such as vulcanizing agents (such as sulfur), accelerators (such as zinc oxide), anti-aging agents, etc., to enhance the stability, elasticity and durability of the latex. S3-4: Asphalt filtration Rinse the mold with hot water after impregnation to remove water-soluble proteins (reducing the risk of allergies) and excess additives from the outer surface of the latex layer; In this step, if the medical gauze used is too thin or the mesh is too sparse, a mold pretreatment step can also be included. Before S3-1, the hand mold is immersed in a coagulant solution (such as 5wt% calcium nitrate, calcium carbonate or calcium acetate solution) to form an isolation layer, which avoids difficulty in demolding after vulcanization. At the same time, it can also make the latex that passes through the gauze mesh adhere evenly to the mold surface.

[0027] During the impregnation process, the thickness of the inner lining and the outer film can be adjusted by controlling the impregnation time (usually a few seconds to tens of seconds) of the mold and the gauze lining being immersed in the latex liquid, as well as the number of impregnations. However, usually one impregnation is sufficient to meet the requirements.

[0028] S4, vulcanization crosslinking First, low-temperature drying and pre-vulcanization are performed, followed by microwave vulcanization, which rapidly cross-links the composite inner lining layer and the latex outer layer to complete the integral molding; specifically, the following steps are included: S4-1: Low-temperature drying and pre-vulcanization Hot air at a temperature not exceeding 70°C is used to heat and dry the wet film, pre-vulcanize it, and cause some latex molecules to undergo cross-linking reaction, initially shape it, and dry the outer layer of the latex. S4-2: Microwave vulcanization Rapid microwave vulcanization at a low temperature not exceeding 70°C allows the composite inner liner to cross-link with the latex outer layer quickly, completing the integral molding and ensuring that the latex of the composite inner liner is completely cured. Specifically, low-temperature rapid microwave vulcanization is carried out at a frequency of 2.45 GHz and a power of 5-10 kW, with the vulcanization temperature controlled below 70℃ and the vulcanization time of 3-5 minutes. This allows the composite inner liner layer and the outer latex layer to cross-link rapidly and complete the integral molding. Microwave vulcanization ensures that the inner latex layer is completely cured. After the final vulcanization is completed, the cross-linking of the molecular chains of the inner and outer latex layers can improve the mechanical properties and chemical resistance of the integral molded product. S5, Post-processing The process involves rolling the edges, demolding, degassing, quality inspection, sterilization, and finally sealing and packaging. Specifically, the steps include: S5-1: Hemming: Fold the wrist edge of the glove inward 1-2 times to form a neat hemmed structure; specifically, this can be done mechanically by using a rotating brush or roller device to fold the wrist edge of the glove inward 1-2 times to form a neat hemmed structure (enhancing sealing and preventing edge tearing during wear); finally, heat setting is performed, and the shape is fixed by brief heating (70-90℃) after hemming to ensure the edge is firm; S5-2: Demolding: Slowly peel the glove off the mold along the mold axis; you can first use automated equipment to loosen the glove from the mold locally by impacting it with compressed air or water (especially the finger area), and then use a robotic arm to hold the edge of the glove and slowly peel it off along the mold axis to avoid tearing; S5-3: Drying: Blow hot air at a temperature below 70°C to dry the outer surface of the gloves; S5-4: Quality Inspection: Perform inflation leak detection, tensile strength test, thickness uniformity test and visual inspection (requires no holes and no impurities); S5-5: Exhaust: The overall flat pressure ensures a tight seal between the top and bottom of the glove's interior, expelling air from inside the glove and sealing the internal space to prevent the volatilization and escape of active ingredients such as ethanol. S5-6: Sterilization: Ethylene oxide (EO) sterilization, temperature 50℃, humidity 60%, EO concentration 600 mg / L, sterilization time 4 hours; S5-7: Sealed Packaging: Each glove should be individually and sealed; specifically, plastic sealing or aluminum foil vacuum packaging can be used to isolate air and prevent the disinfecting active ingredients inside the gloves from being oxidized during storage.

[0029] The composite formulation of alcohol (ethanol)-carboxymethyl chitosan-traditional Chinese medicine extract provided in this embodiment of the invention shows the best performance after comprehensive comparison with other similar formulations. It has good bactericidal effect, good sustained-release performance, and is skin-friendly. At the same time, the preparation process is relatively simple and easy to mass-produce.

[0030] The following describes the process in detail with reference to several specific embodiments.

[0031] Example 1 See Figures 3-4 The medical pre-sterilized full-process protective gloves and their preparation method provided in this embodiment are specific selections and applications based on the basic embodiment. The structure of the medical pre-sterilized full-process protective gloves is exactly the same as that in the basic embodiment, except that: For medical gauze, choose high-count, high-density combed cotton gauze, Ne 40 / 1, with a warp and weft density of 24×20; The ethanol-herbal sustained-release disinfectant gel is made from the following components by mass percentage: 70% ethanol, 1.5% carboxymethyl chitosan, 2% glycerol, 3% herbal compound extract, 0.15% hydrogen peroxide, 0.1% sodium alginate, 0.02% β-cyclodextrin-encapsulated baicalin, and the balance being deionized water. The herbal compound extract is made from the following components by weight percentage: The contents consist of 8% Scutellaria baicalensis extract, 6.5% Lonicera japonica extract, 4.5% Clove extract, 1.5% Mentha haplocalyx extract, and the remainder is deionized water.

[0032] The medical pre-sterilized full-protection latex gloves provided in this embodiment are specifically medium-sized (M type), with a rolled edge circumference of 20-22cm and a total thickness of approximately 0.3-0.4mm for both inner and outer layers. They are highly versatile and can cover most adults. Figures 3-4 This is a schematic diagram of the three-dimensional outline of the latex glove product prepared in this embodiment. The texture of the gauze in the composite inner lining layer can be seen from the figure. It is clearly visible through the outer latex layer. Some of the raised textures also form the surface texture of the outer latex layer, which increases the friction of the outer layer, improves the anti-slip ability, and significantly enhances the structural strength and operational flexibility of the glove product.

[0033] Example 2 See Figure 5 The medical pre-sterilized full-process protective gloves and their preparation method provided in this embodiment are basically the same as those in Embodiment 1, except that: The ethanol-herbal sustained-release disinfectant gel is made from the following components by mass percentage: 72.5% ethanol, 1% carboxymethyl chitosan, 2.5% glycerol, 3.5% herbal compound extract, 0.1% hydrogen peroxide, 0.15% sodium alginate, 0.05% β-cyclodextrin-encapsulated baicalin, and the balance being deionized water. The herbal compound extract is made from the following components by weight percentage: The contents consist of 9.5% Scutellaria baicalensis extract, 5% Lonicera japonica extract, 3.5% Clove extract, 2% Mentha haplocalyx extract, and the remainder is deionized water.

[0034] The medical pre-sterilized full-protection latex gloves provided in this embodiment are specifically extra-large (XL) size: the rolled edge circumference is 25cm or more, and the wrist area is extended. The total thickness of the inner and outer layers is approximately 0.4-0.6mm to accommodate higher protection levels and other special needs. As shown in the figure, these medical pre-sterilized full-protection gloves can completely cover the hands and wrists of medical personnel in use, and can carry a larger total amount of slow-release disinfectant gel, thus providing stronger disinfection and protection effects. The texture of the gauze lining of the composite inner layer forms the surface texture of the outer latex layer through the outer latex layer, increasing surface friction and giving the gloves an anti-slip effect.

[0035] Example 3 The medical pre-sterilized full-process protective gloves and their preparation method provided in this embodiment are basically the same as those in Embodiments 1-2, except that: The ethanol-herbal sustained-release disinfectant gel is made from the following components by mass percentage: 75% ethanol, 2% carboxymethyl chitosan, 3% glycerol, 5% herbal compound extract, 0.2% hydrogen peroxide, 0.2% sodium alginate, 0.03% β-cyclodextrin-encapsulated baicalin, and the balance being deionized water. The herbal compound extract is made from the following components by weight percentage: The contents consist of 10% Scutellaria baicalensis extract, 7.5% Lonicera japonica extract, 3% Clove extract, 1% Mentha haplocalyx extract, and the remainder is deionized water.

[0036] Example 4 The medical pre-sterilized full-process protective gloves and their preparation method provided in this embodiment are basically the same as those in Examples 1-3, except that: The ethanol-herbal sustained-release disinfectant gel is made from the following components in the indicated mass percentages: 74% ethanol, 1.75% carboxymethyl chitosan, 2.75% glycerol, 4.5% herbal compound extract, 0.15% hydrogen peroxide, 0.16% sodium alginate, 0.04% β-cyclodextrin-encapsulated baicalin, and the balance being deionized water. The herbal compound extract is made from the following components by weight percentage: The contents consist of 8.5% Scutellaria baicalensis extract, 8% Lonicera japonica extract, 5% Clove extract, 1.75% Mentha haplocalyx extract, and the remainder is deionized water.

[0037] The preparation process and products provided in the above embodiments of the present invention can all be mass-produced through highly automated production lines, and the products can simultaneously meet the requirements of medical gloves in terms of protection, comfort and biosafety.

[0038] The medical pre-sterilized full-process protective glove samples provided in the above embodiments of the present invention have passed the EN 455 series tests (non-porousness, physical properties, biological evaluation) after actual testing, and meet the following domestic standards: GB7543-2006 Material and technical requirements for sterile rubber surgical gloves; GB 10213-2006 Technical specifications for medical rubber examination gloves; GB 24788-2009 Limits on residual powder and protein on the surface of gloves, and are suitable for industrial application.

[0039] It should be noted that in other embodiments of the present invention, other different solutions obtained by making specific selections within the scope of the product shape, structure, formula components, proportions, preparation steps, process parameters and conditions, etc., as described in the present invention, can all achieve the technical effects described in the present invention. Therefore, the present invention will not list them one by one.

[0040] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention in any way. Any person skilled in the art can make many possible variations and modifications to the technical solution of the present invention using the methods and techniques disclosed above, or modify it into equivalent embodiments with equivalent changes, without departing from the scope of the present invention. All equivalent changes made to the components, proportions, and processes of the present invention should be covered within the protection scope of the present invention.

Claims

1. A medical pre-sterilized full-process protective glove, characterized in that, It includes a latex glove body (1), which is made of an integrally molded latex outer layer (2) and a drug-soaked gauze inner lining layer (3); the drug-soaked gauze inner lining layer (3) is made by soaking medical gauze in ethanol-herbal sustained-release disinfectant gel and then drying it; the ethanol-herbal sustained-release disinfectant gel has weak adhesion, and when not in use, the upper and lower parts of the latex glove body are bonded together, which expels the air inside the latex glove body and seals the opening of the latex glove body to prevent the active ingredients from evaporating and escaping; during use, the drug-soaked gauze inner lining layer (3) slowly releases the active ingredients in the ethanol-herbal sustained-release disinfectant gel to continuously provide active protection; The ethanol-herbal sustained-release disinfectant gel is made from the following components in the indicated mass percentages: 70-75% ethanol, 1-2% carboxymethyl chitosan, 2-3% glycerol, 3-5% herbal compound extract, 0.1-0.2% hydrogen peroxide, 0.1-0.2% sodium alginate, 0.02-0.05% β-cyclodextrin-encapsulated baicalin, with the balance being deionized water. The herbal compound extract is composed of the following components by mass percentage: 8-10% Scutellaria baicalensis extract, 5-8% Lonicera japonica extract, 3-5% Clove extract, 1-2% Mentha haplocalyx extract, with the remainder being deionized water; the volume concentration of ethanol is 95%. The medical gauze described is a hollow polyester / cotton composite gauze that has undergone low-temperature plasma surface activation treatment; Each glove's medicated gauze lining (3) includes an upper piece (31) and a lower piece (32) with a symmetrical structure. After being vulcanized with the latex outer layer (2), they correspond to form the upper and lower surfaces of the latex glove body (1) with weak adhesion.

2. A method for preparing the medical pre-sterilized full-process protective gloves as described in claim 1, characterized in that, It includes the following steps: S1: Preparation of ethanol-herbal sustained-release disinfectant gel First, prepare the herbal compound extract; then add carboxymethyl chitosan to an appropriate amount of deionized water and stir continuously until the carboxymethyl chitosan is completely dissolved. Adjust the pH value to 6.0~7.0 to obtain a carboxymethyl chitosan gel solution; then, at low temperature, add the carboxymethyl chitosan gel solution, glycerol, herbal compound extract, sodium alginate, β-cyclodextrin-encapsulated baicalin, and ethanol to deionized water and homogenize. Finally, add hydrogen peroxide and homogenize again to obtain an ethanol-herbal sustained-release disinfectant gel, and let it stand at a low temperature not exceeding 15°C for later use. S2. Preparation of the drug-impregnated gauze lining layer The medical gauze was pretreated with plasma surface activation, then immersed in ethanol-herbal sustained-release disinfectant gel, vacuumed, and then dried with hot air circulation at no more than 40°C to control the final moisture content at 5~8wt%. It was then cut into gauze upper and lower pieces with a symmetrical structure that matched the shape and size of the glove mold. S3, Dip molding The cut upper and lower pieces of gauze are adhered to the mold surface using their inherent weak adhesiveness. The mold, along with the gauze patch, is then immersed in a diluted latex solution with a solid content of 15-20 wt%, and quickly removed. The gauze patch and the diluted latex solution together form a composite inner lining layer. The mold is then immersed in a latex solution with a solid content of 30-35 wt%, and quickly removed, forming a latex outer layer with a thickness of 0.2-0.5 mm. Both the latex solution and the diluted latex solution are made by mixing natural latex and nitrile rubber in a 7:3 mass ratio. After immersion, the mold is rinsed and filtered with hot water to remove water-soluble proteins and excess additives from the outer surface of the latex outer layer. S4, vulcanization crosslinking First, the wet film is dried and pre-cured with hot air at low temperature to cause some latex molecules to undergo cross-linking reaction and preliminary shaping, and the outer layer of latex is dried. Then, low-temperature rapid microwave curing is carried out at a frequency of 2.45GHz and a power of 5-10kW for 3-5 minutes to rapidly cross-link the composite inner liner and the outer latex layer, complete the integral molding, and ensure that the latex of the composite inner liner is completely cured. S5, Post-processing The process involves rolling the edges, demolding, venting, quality inspection, sterilization, and finally sealing and packaging.

3. The method for preparing medical pre-sterilized full-process protective gloves according to claim 2, characterized in that, Specifically, S1 includes the following steps: S1-1: Preparation of raw materials Ethanol, carboxymethyl chitosan, glycerol, hydrogen peroxide, Scutellaria baicalensis extract, Lonicera japonica extract, Clove extract, Mentha haplocalyx extract, sodium alginate, β-cyclodextrin-encapsulated baicalin, and deionized water were prepared separately. S1-2: Preparation of herbal compound extract Scutellaria baicalensis extract, Lonicera japonica extract, Clove extract, and Mentha haplocalyx extract were added to the remaining deionized water and homogenized to obtain a herbal compound extract. S1-3: Preparation of carboxymethyl chitosan gel liquid Add carboxymethyl chitosan to an appropriate amount of deionized water and stir continuously until the carboxymethyl chitosan is completely dissolved. Adjust the pH value to 6.0~7.0 to obtain carboxymethyl chitosan gel solution. S1-4: Preparation of ethanol-herbal sustained-release disinfectant gel Carboxymethyl chitosan gel, glycerol, herbal compound extract, sodium alginate, β-cyclodextrin-encapsulated baicalin, and ethanol were added to deionized water and homogenized. Finally, hydrogen peroxide was added and homogenized again to obtain an ethanol-herbal sustained-release disinfectant gel, which was then allowed to stand at low temperature for later use.

4. The method for preparing medical pre-sterilized full-process protective gloves according to claim 2, characterized in that, Its S2 specifically includes the following steps: S2-1: Pretreatment of medical gauze Plasma surface activation treatment was applied to medical gauze. S2-2: Vacuum impregnation The pretreated medical gauze was immersed in ethanol-herbal sustained-release disinfectant gel, and a vacuum was drawn to maintain a vacuum degree of -0.08MPa for 3-5 minutes. S2-3: Low-temperature drying Dry with hot air circulation at a temperature not exceeding 40℃ for 20-30 minutes to control the final moisture content to 5-8 wt%. S2-4: Symmetrical Cutting The medical gauze is cut into upper and lower pieces that match the shape and size of the glove mold and have a symmetrical structure.

5. The method for preparing medical pre-sterilized full-process protective gloves according to claim 2, characterized in that, Its S3 specifically includes the following steps: S3-1: Gauze lining fit The pre-treated and cut gauze lining, including the upper and lower pieces, is attached to the mold surface using its own weak adhesiveness. S3-2: First immersion The mold, along with the gauze lining, is immersed in a dilute latex solution with a solid content of 15-20 wt% for 5-10 seconds, allowing the dilute latex solution to fully penetrate the cotton yarns of the gauze lining and the gaps between the cotton yarns, forming a composite lining layer. S3-3: Second immersion Then immerse it in a latex solution with a solid content of 30-35 wt% for 10-15 seconds to form a latex outer layer with a thickness of 0.2-0.5 mm; S3-4: Asphalt filtration After impregnation, the mold is rinsed with hot water to remove water-soluble proteins and excess additives from the outer surface of the latex layer.

6. The method for preparing medical pre-sterilized full-process protective gloves according to claim 2, characterized in that, Its S4 specifically includes the following steps: S4-1: Low-temperature drying and pre-vulcanization Hot air at a temperature not exceeding 80°C is used to heat and dry the wet film, pre-vulcanizing it to cause some latex molecules to undergo cross-linking reaction, initially shaping it, and drying the outer layer of the latex. S4-2: Microwave vulcanization Rapid microwave vulcanization at a low temperature not exceeding 80℃ allows the composite inner liner to quickly cross-link with the latex outer layer, completing the integral molding and ensuring that the latex of the composite inner liner is completely cured.

7. The method for preparing medical pre-sterilized full-process protective gloves according to claim 2, characterized in that, Its S5 specifically includes the following steps: S5-1: Demolding: Slowly peel the gloves off the mold along the mold axis; S5-2: Curling: Fold the edge of the glove at the wrist inward 1-2 times to form a neat curled edge structure; S5-3: Drying: Blow hot air at a temperature below 70°C to dry the outer surface of the gloves; S5-4: Quality Inspection: Perform inflation leak detection, tensile strength testing, thickness uniformity testing, and visual inspection; S5-5: Exhaust: Apply overall pressure to ensure a tight seal between the top and bottom of the glove's interior, expelling air from inside the glove; S5-6: Sterilization: Ethylene oxide sterilization; S5-7: Sealed Packaging: Each glove shall be individually and sealed.

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