Requirements for Classification, Production and Testing of Medical Gloves

May. 21, 2020 | 17:20:39

As one of the important medical protection products for epidemic prevention and control, medical gloves play an important role in the protection of medical personnel. Medical making machine factory share this article for you:

1. Classification and management of medical gloves

Medical gloves include sterile medical surgical gloves, medical sterile examination gloves, medical examination gloves (not sterile provided).

Sterile medical surgical gloves, medical sterile examination gloves, management category II, original classification code 6866, now classification code 14 (non-sterile medical examination gloves, management category I, original classification code 6866, now classification code 14 ).

Sterile medical surgical gloves are suitable for protective use during clinical surgical operations. They are used on the hands of surgical staff to prevent the spread of dander and bacteria to open surgical wounds, and prevent the spread of surgical patients' body fluids to medical staff. The role of two-way biological protection.

Medical (sterile) examination gloves are used to check or touch the patient's condition on the doctor's hand or finger to prevent cross infection between the patient and the user during the medical examination and diagnosis and treatment.

2. The structure of medical gloves

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

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

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

According to the type of rubber, it can be divided into 1 type, 2 type and 3 type.

Such as: rubber surgical gloves, type 1 refers to gloves made of natural rubber latex;

Type 2 is a glove made from nitrile rubber latex, neoprene rubber latex, styrene butadiene rubber solution or emulsion, thermoplastic elastomer solution or emulsion;

Type 3 is a glove made by mixing or compounding materials of type 1 and type 2.

According to the design style, it can be divided into straight type (R type) and curved type (C type).

According to the surface type, it is divided into: pitted surface (T type), smooth surface (S type), with powder (P type), without powder (F type).

3. Test items for medical gloves

(1) Sterile medical surgical gloves

It should comply with GB 7543-2006 "Disposable Sterilized Rubber Surgical Gloves", GB 24787-2009 "Disposable Non-sterilized Rubber Surgical Gloves", and GB 24788-2009 "Limits for Residual Powder on the Surface of Medical Gloves and Water Extracted Protein" Requirements.

(2) Medical examination gloves

It should meet the requirements of GB 10213-2006 "Disposable Rubber Examination Gloves", GB 24786-2009 "Disposable Polyvinyl Chloride Medical Examination Gloves", and GB 24788-2009 "Limit of Residual Powder on the Surface of Medical Gloves and Water Extraction Protein" Requirements.

(3) Residual amount of ethylene oxide (if sterilized with ethylene oxide)

It should meet the relevant requirements in GB / T 16886.7-2001 "Medical Device Biological Evaluation Part 7 Ethylene Oxide Sterilization Residues"; if there are endotoxin requirements, it should also meet YY / T 0616-2007 "Single Use Relevant requirements in Biological Evaluation Requirements and Tests of Medical Gloves.

Our company provides a series of medical glove production line. If you have any demand for our products, please feel free to contact us.

Medical Making Machine Factory

Medical Making Machine Factory