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GB 24788: Evolution and historical versions
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| GB 24788-2025 | English | 125 |
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Safety technical requirements for medical gloves
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| GB 24788-2009 | English | 90 |
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Limit for the removable surface powder and water-extractable protein of medical gloves
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GB 24788-2025: Safety technical requirements for medical gloves
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GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.140
CCS G 45
Replacing GB 24788-2009
Safety Technical Requirements for Medical Gloves
Issued on: MAY 30, 2025
Implemented on: JUNE 1, 2028
Issued by. State Administration for Market Regulation;
Standardization Administration of the People’s Republic of China.
Table of Contents
Foreword... 3
1 Scope... 4
2 Normative References... 4
3 Terms and Definitions... 4
4 Safety Technical Requirements... 5
5 Test Method... 6
Safety Technical Requirements for Medical Gloves
1 Scope
This document specifies the safety technical requirements for medical gloves.
This document applies to disposable medical rubber examination gloves, disposable sterile
rubber surgical gloves, disposable non-sterile rubber surgical gloves, and disposable polyvinyl
chloride medical examination gloves.
2 Normative References
The contents of the following documents constitute indispensable clauses of this document
through the normative references in the text. In terms of references with a specified date, only
versions with a specified date are applicable to this document. In terms of references without a
specified date, the latest version (including all the modifications) is applicable to this document.
GB/T 14233.1-2022 Test Methods for Infusion, Transfusion, Injection Equipment for Medical
Use - Part 1.Chemical Analysis Methods
GB 15979-2024 Hygienic Requirements for Disposable Sanitary Products
GB/T 21869-2008 Medical Gloves - Determination of Removable Surface Powder
GB/T 21870-2008 Medical Gloves Made from Natural Rubber Latex - Determination of Water-
extractable Protein Using the Modified Lowry Method
Pharmacopoeia of the People’s Republic of China (Version 2020) Volume IV
3 Terms and Definitions
The following terms and definitions are applicable to this document.
3.1 powder
Under test conditions, any water-insoluble adhering matter on the surface of medical gloves
that can be removed by washing with water.
3.2 powdered medical gloves
Medical gloves that are typically produced through the powder coating process during the
production process for ease of donning.
3.3 powder-free medical gloves
Medical gloves produced in the glove production process where the powder coating process is
intentionally not used, or where the powder coating process is used, but the power is
intentionally removed.
3.4 water-extractable protein
Proteins and polypeptides that exist in natural rubber latex products and can be extracted with
water.
4 Safety Technical Requirements
4.1 Limit for Water-extractable Protein
Medical gloves made from natural rubber latex shall contain no more than 200 g/dm2 of water-
extractable protein.
4.2 Limit for Residual Surface Powder
The residual surface powder content of powdered medical gloves shall not exceed 15 mg/dm2.
The residual surface powder content of powder-free medical gloves shall not exceed 2.0
mg/piece.
NOTE. the limit for residual surface powder does not apply to disposable polyvinyl chloride
medical examination gloves.
4.3 Microbiological Indicators
4.3.1 The microbiological indicators of non-sterile medical gloves shall comply with the
provisions of Table 1.
4.3.2 Sterilized gloves shall be sterile.
4.4 Ethylene Oxide Residue
The ethylene oxide residue of medical gloves sterilized with ethylene oxide shall not exceed 10
g/cm2.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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