GB24788-2009

Limit for the removable surface powder and water-extractable protein of medical gloves

医用手套表面残余粉末、水抽提蛋白质限量

GB 24788-2009 es una norma nacional china obligatoria vigente: Limit for the removable surface powder and water-extractable protein of medical gloves. Sector: Electrónica. Enfoque: Seguridad de productos. Entrada en vigor: 1 oct 2010.

La aplicabilidad depende del alcance del producto, la vía de certificación, los avisos de la autoridad competente y las reglas de transición. Solicite una traducción o verifique la fuente antes de usar esta ficha en una decisión de cumplimiento.

Resumen de cumplimiento

Este resumen está disponible por ahora solo en inglés.

Alcance y aplicabilidad

This standard applies to medical gloves including single-use rubber examination gloves, sterile rubber surgical gloves, nitrile rubber examination gloves, PVC examination gloves, and non-sterile rubber surgical gloves. It is specifically designed for products manufactured from natural rubber latex and other materials where powdering is used. Manufacturers of these medical devices must comply with these limits to sell in the Chinese market.

Requisitos técnicos

The standard specifies the maximum allowable limits for removable surface powder and water-extractable protein on medical gloves. Clause 4.1 and 4.2 are mandatory requirements. For gloves made from natural rubber latex, the standard sets a strict limit on the content of water-extractable proteins to prevent allergic reactions. Additionally, it distinguishes between powdered and powder-free gloves, establishing separate maximum thresholds for residual powder on the glove surface. Compliance with these specific numerical limits is mandatory for all applicable medical gloves. The standard references ISO 21171:2006 and ISO 12243:2003 for relevant testing methodologies.

Métodos de ensayo

Testing for water-extractable protein content in natural rubber latex gloves must be conducted according to the modified Lowry method specified in GB/T 21870-2008 (Method A). The determination of removable surface powder is performed according to GB/T 21869-2008, which involves calculating the total surface area of the glove based on measured width and length to determine the powder concentration per unit area.

Preguntas frecuentes

What products are regulated under GB 24788-2009?

It regulates single-use medical rubber examination gloves, sterile rubber surgical gloves, nitrile rubber examination gloves, PVC medical examination gloves, and non-sterile rubber surgical gloves.

Are the requirements in GB 24788-2009 mandatory?

Yes, Clause 4.1 regarding water-extractable protein limits and Clause 4.2 regarding surface residual powder limits are mandatory. The remaining clauses are recommended.

Does GB 24788-2009 differentiate between powdered and powder-free gloves?

Yes, the standard sets distinct residual powder limits for powdered gloves versus powder-free gloves to ensure safety and compliance based on the manufacturing process.

The summary above provides a high-level overview of GB 24788-2009. 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 24788-2009 today to access all detailed parameters, tables, and testing procedures.

Indicaciones de aplicabilidad

Tipo: Seguridad
CCS: G45
ICS: 83.140.99
Organismo competente: Ministry of Industry and Information Technology
Comité técnico: Ministry of Industry and Information Technology

Relaciones

Sustituida por:GB 24788-2025 (Próxima)