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GB24788-2025
Safety technical requirements for medical gloves
医用手套安全技术要求
GB 24788-2025 — вступающий в силу обязательный национальный стандарт Китая: Safety technical requirements for medical gloves. Отрасль: Электроника. Тема: Безопасность продукции. Дата вступления в силу: 1 июн. 2028 г..
Применимость зависит от продукции, схемы сертификации, уведомлений компетентных органов и переходных правил. Закажите перевод или проверьте источник, прежде чем использовать эту запись в решениях по соответствию.
Обзор требований
Этот обзор пока доступен только на английском языке.
Область применения
This standard specifies the safety technical requirements for medical gloves. It applies to single-use medical rubber examination gloves, single-use sterile rubber surgical gloves, single-use non-sterile rubber surgical gloves, and single-use polyvinyl chloride (PVC) medical examination gloves. Manufacturers of these specific medical glove categories must comply with this standard. It replaces the previous GB 24788-2009.
Технические требования
The standard outlines critical safety parameters for medical gloves, focusing on biological and chemical safety. It specifies water-extractable protein limits for gloves made from natural rubber latex to minimize allergy risks. Additionally, it defines surface residual powder limits, distinguishing between powdered and powder-free gloves, though this specific requirement does not apply to PVC examination gloves. The standard also introduces microbial limits for non-sterile gloves and mandates that sterilized gloves must be completely sterile. Finally, it sets strict ethylene oxide residue limits for gloves sterilized using this method. Compliance with these chemical and biological thresholds is mandatory for market access.
Методы испытаний
Testing procedures are defined to verify compliance with the technical requirements. Water-extractable protein content is determined using the modified Lowry method as per GB/T 21870-2008. Surface residual powder is measured according to GB/T 21869-2008, which includes a specific formula for calculating glove surface area. Microbial testing for non-sterile gloves follows GB 15979-2024, while sterility testing for sterilized gloves adheres to the Pharmacopoeia of the People's Republic of China. Ethylene oxide residue is tested according to GB/T 14233.1-2022. Accurate execution of these referenced methods is essential for valid compliance certification.
Частые вопросы
What products are regulated under GB 24788-2025?
It regulates single-use medical rubber examination gloves, sterile and non-sterile rubber surgical gloves, and single-use PVC medical examination gloves.
What are the key updates in GB 24788-2025 compared to the 2009 version?
The 2025 version updates the residual powder limits for powdered gloves, adds requirements for microbial indicators and ethylene oxide residues, and modifies the glove surface area calculation formula.
Does the surface residual powder limit apply to all medical gloves?
No, the surface residual powder limit does not apply to single-use polyvinyl chloride (PVC) medical examination gloves.
The summary above provides a high-level overview of GB 24788-2025. To ensure complete compliance for your products entering the Chinese market, a precise and professional translation of the full technical specifications is essential. Purchase our high-quality English translation of GB 24788-2025 today to access all detailed parameters, tables, and testing procedures.
Подсказки по применимости
- Тип
- Продукция
- CCS
- G45
- ICS
- 11.140
- Компетентное ведомство
- Ministry of Industry and Information Technology
- Технический комитет
- National Technical Committee on Rubber and Rubber Products of Standardization Administration of China
Связи
Заменяет:GB 24788-2009 (Действует)