Requirement standards for doctor's glove production line

In recent years, the standards for medical equipment have become increasingly stringent. Among them, disposable medical gloves, which are used very frequently, are one of them. So what are the requirements for disposable medical gloves for production equipment? Let's take a look:

1. Classification and management of medical gloves

Medical gloves include sterile medical surgical gloves, medical sterile examination gloves, and medical examination gloves (non-sterile).

Sterile medical surgical gloves and medical sterile examination gloves, management category II, original classification code 6866, current classification code 14. Non-sterile medical examination gloves, management category I, original classification code 6866, current classification code 14.

Sterile medical surgical gloves are suitable for protection during clinical surgical operations. They are worn on the hands of surgical personnel to prevent dandruff and bacteria from spreading to open surgical wounds, and to prevent the body fluids of surgical patients from spreading to medical personnel, playing a two-way biological protection role.

Medical (sterile) examination gloves are used to be worn on the doctor's hands or fingers to examine or touch the patient's condition, and to prevent cross infection between the patient and the user during medical examination and diagnosis and treatment.

2. Structural composition of medical gloves

Medical surgical gloves are generally made of natural rubber latex, nitrile rubber latex, chloroprene rubber latex, styrene-butadiene rubber or thermoplastic elastomer solution or emulsion, styrene-butadiene rubber latex and other materials.

Medical (sterile) examination gloves are generally made of natural rubber latex, nitrile rubber latex, chloroprene rubber latex, styrene-butadiene rubber or thermoplastic elastomer solution or emulsion, styrene-butadiene rubber latex, polyvinyl chloride, polyethylene and other materials.

3. Medical gloves are classified according to rubber type, design, and surface type, and generally have the following forms:

According to rubber type, they are divided into: Type 1, Type 2, and Type 3.

For example: rubber surgical gloves, type 1 refers to gloves made of natural rubber latex;

Type 2 refers to gloves made of nitrile rubber latex, chloroprene rubber latex, styrene-butadiene rubber solution or emulsion, thermoplastic elastomer solution or emulsion;

Type 3 refers to gloves made by mixing or compounding materials of type 1 and type 2.

According to the design style, they are divided into: straight type (R type) and curved type (C type).

According to the surface type, they are divided into: hemp surface (T type), smooth surface (S type), powdered (P type), and powder-free (F type).

4. Testing items for medical gloves

(I) Sterile medical surgical gloves:

Should comply with the requirements of GB 7543-2006 "Disposable Sterile Rubber Surgical Gloves", GB 24787-2009 "Disposable Non-sterile Rubber Surgical Gloves", and GB 24788-2009 "Limits of Residual Powder and Water-Extractable Protein on the Surface of Medical Gloves".

(II) Medical examination gloves:

Should comply with the requirements of GB 10213-2006 "Disposable Rubber Examination Gloves", GB 24786-2009 "Disposable Polyvinyl Chloride Medical Examination Gloves", and GB 24788-2009 "Limits of Residual Powder and Water Extractable Protein on the Surface of Medical Gloves".

(III) For ethylene oxide sterilization, the ethylene oxide residue

Should comply with the relevant requirements in GB/T 16886.7-2001 "Biological Evaluation of Medical Devices Part 7 Ethylene Oxide Sterilization Residues"; if there are endotoxin requirements, they should also comply with the relevant requirements in YY/T 0616-2007 "Biological Evaluation Requirements and Tests for Disposable Medical Gloves".

5. Production process requirements

(I) Product manufacturing related requirements

The production process of medical gloves should be clearly defined, key processes and special processes should be indicated in the process flow chart, and their process control points should be explained. Clarify the use of various processing aids in the production process and the control of impurities (such as residual monomers, small molecular residues, etc.).

The production process of medical rubber gloves generally includes: batching, mold cleaning (hand mold acid and alkali cleaning, hand mold water washing, hand mold immersion in hot water), hand mold immersion in coagulant, drying, dipping, drying, curling, leaching, immersion in isolation agent/chlorine treatment, drying, demoulding, vulcanization, drying molding, primary packaging, sterilization (if any), etc. Among them, the key processes and special processes are: leaching, chlorine treatment, vulcanization, primary packaging, sterilization (if any), etc.

The production process of disposable sterile polyvinyl chloride medical examination gloves generally includes: batching, filtration, degassing, dipping, plasticization, powdering, sorting, demoulding, packaging, etc. Key processes and special processes include: degassing, dipping, plasticization, packaging, etc.

Attention should be paid to the quality control requirements of raw materials for medical gloves, and the source and quality requirements of raw materials should be clarified. The raw materials should have a relatively stable production process and supply source to ensure the quality of the product. Raw materials should be stored to prevent moisture, contamination and pests, especially latex and starch must be stored in an environment that can prevent the growth of microorganisms.

(II) Sterilization process requirements

The sterilization process (method and parameters) and sterility assurance level (SAL) should be clearly defined, and a sterilization confirmation report should be provided. For products sterilized by end users, the recommended sterilization process (method and parameters) and the basis for the recommended sterilization method should be clearly defined. If ethylene oxide sterilization is used, the residue requirements and treatment methods should be clearly defined, and research data should be provided.

(III) Product expiration date

The basis for determining the expiration date of medical gloves and related verification data should be provided, and reference can be made to EN 455-4-2009 "Disposable medical gloves - Requirements and tests for determining shelf life". And research data on maintaining the integrity of the packaging within the declared expiration date and under transportation and storage conditions.

6. Product instructions and labeling requirements

Product instructions and labels shall comply with the "Regulations on the Management of Medical Device Instructions and Labels" (Order No. 6 of the State Food and Drug Administration), "Medical Devices Symbols for Labeling, Marking and Information Provision of Medical Devices Part 1: General Requirements" (YY/T 0466.1-2009) and relevant standards.

(I) The inner packaging should clearly indicate:

(1) Size;

(2) "Left" or "Right" should be marked on the inner packaging;

(3) Powdered gloves should have the following instructions: "Caution: Surface powder should be removed aseptically before surgery to minimize the risk of adverse tissue reactions." or "Once gloves have been treated with any surface powder material, there should be a warning and the surface powder should be removed aseptically before surgery." or equivalent instructions;

(4) Gloves made of natural rubber latex should have the following instructions: "(Product) contains natural rubber latex that may cause allergic reactions" or equivalent instructions;

(5) If the product is labeled as containing protein, the specified process limit should be given;

(6) "Hypoallergenicity" should not be labeled.

(II) Unit packaging generally includes the following:

(1) The name or trademark of the manufacturer or supplier;

(2) The materials used;

(3) "straight fingers" or "curved fingers", or similar words indicating the design of the gloves;

(4) "hemp surface" or "glossy surface", "powdered" or "powder-free", or words that have a similar effect on the type of gloves;

(5) Size;

(6) Product production batch number, production date, use period or expiration date;

(7) Indication of product status: "sterile, unless the package is opened or damaged" or "non-sterile";

(8) The words "single use";

(9) The words "surgical gloves" or "examination gloves";

(10) For Category 1 gloves, the words "the product is made of natural rubber latex that may cause allergic reactions" etc.

(11) The product must not be exposed to oil, acid, alkali, copper, manganese or other organic solvents during storage. Avoid exposure to sunlight or artificial light containing ultraviolet components. There should be no ozone generating device in the warehouse and it should be kept away from radioactive materials.

(III) Multi-unit packaging

Multi-unit packaging is a box of products with a predetermined number of gloves of the same size, the purpose of which is to facilitate safe transportation and storage. Multi-unit packaging is marked as single packaging and should indicate the number of gloves and additional storage instructions.

Nanjing Sumino Precision Machinery Co., Ltd. has a professional cast film production line. The company's main cast film manufacturing production lines include: TPU hot melt adhesive film production line, CPP/CPE cast film production line, EVA solar encapsulation adhesive film production line, PE sanitary breathable film production line, PVDF cast film production line, PP three-dimensional film production line, medical blood purification film production line, multi-layer co-extrusion barrier film production line, LLDPE wrapping film production line, etc.