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GB 24788-2025Safety technical requirements for medical gloves (English PDF)

医用手套安全技术要求

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Issued by

State Administration for Market Regulation; Standardization Administration of China

Level / Type

National · Mandatory

Issue date

May 30, 2025

Implementation date

June 1, 2028

Scope

GB 24788-2025 is the English-translated version of 医用手套安全技术要求.

GB 24788-2025 is the Chinese national standard on safety technical requirements for medical gloves, in the field of health care technology. It carries no /T suffix, which in the Chinese system means compliance is mandatory: a product or a practice within its scope has to meet it to be lawfully made, sold or carried out in China.

It was issued on 30 May 2025 by the State Administration for Market Regulation; Standardization Administration of China, and takes effect on 1 June 2028. Classification: ICS 11.140, CCS G45.

This page is published from the official record of the standard held by the Chinese standards administration: the identification, the dates, the classification and the issuing body are taken from there.

The clause text, the tables and the numeric limits are in the document itself, which is delivered complete in English translation.

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Document preview — GB 24788-2025

National Standard of the People's Republic of China

ICS: 11.140
Classification: G45

Issued by: State Administration for Market Regulation; Standardization Administration of China

1 Scope
2 Normative References
3 Terms and Definitions
4 Safety Technical Requirements
5 Test Method

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/dm 2 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/dm 2.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/cm 2.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 10 pages — is available in the English PDF.

Referenced standards

Normative references

Similar standards

GB 10152-2009|GB 11417.2-2012|GB 11417.2-2025|GB 11417.3-2012|GB 11417.3-2025

Editions of GB 24788

Edition	Title	Revision	Status
GB 24788-2025	Safety technical requirements for medical gloves	current edition	Current
GB 24788-2009	Limit for the removable surface powder and water-extractable protein of medical gloves	previous edition	Superseded

This page sells the current edition, GB 24788-2025. Earlier editions are listed for reference only.

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