Classification, Production and Inspection Requirements of Medical Gloves (Part 1)

Classification, Production and Inspection Requirements of Medical Gloves (Part 1)

Medical making machine factory share with you:

01. Classification and management of medical gloves

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

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

Sterile medical surgical gloves are suitable for protective use during clinical surgical operations. They are worn on the hands of surgeons to prevent the spread of dandruff and bacteria to open surgical wounds and prevent the body fluids of surgical patients from being transmitted to medical personnel. The role of two-way biological protection.

Medical (sterile) examination gloves are used to check or touch the patient's condition while being worn on the doctor's hand or fingers to prevent cross-infection between the patient and the user during the medical examination and diagnostic treatment.

02. Structural composition of medical gloves

Medical glove production line believes that medical surgical gloves are generally made of natural rubber latex, nitrile rubber latex, neoprene latex, styrene-butadiene rubber r 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 and surface type, and generally have the following forms:

Divided by rubber type: 1 type, 2 type, 3 type.

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

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

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

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

According to the surface type, it can be divided into: hemp surface (T type), smooth surface (S type), powder (P type), powderless (F type).

03. Test items of medical gloves

(A) sterile medical surgical gloves:

Should comply with GB 7543-2006 "Single-use sterile rubber surgical gloves", GB 24787-2009 "Single-use non-sterile rubber surgical gloves", GB 24788-2009 "Limits of residual powder on the surface of medical gloves, water extraction protein" Requirements.

(2) Medical examination gloves:

Should meet the requirements of GB 10213-2006 "Single-Use Rubber Examination Gloves", GB 24786-2009 "Single-Use Polyvinyl Chloride Medical Examination Gloves", GB 24788-2009 "Limits of Residual Powder and Water Extraction Protein on the Surface of Medical Gloves" Requirements.

(2) Medical examination gloves:

Should meet the requirements of GB 10213-2006 "Single-Use Rubber Examination Gloves", GB 24786-2009 "Single-Use Polyvinyl Chloride Medical Examination Gloves", GB 24788-2009 "Limits of Residual Powder and Water Extraction Protein on the Surface of Medical Gloves" Requirements.

(3) Residual ethylene oxide when sterilized with ethylene oxide

It shall meet the relevant requirements in GB / T 16886.7-2001 "Ethylene Oxide Sterilization Residues in Biological Evaluation of Medical Devices, Part 7"; if there are endotoxin requirements, it shall also comply with YY / T 0616-2007 "Single use Medical gloves biological evaluation requirements and tests.

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