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 ist eine gültige verbindliche chinesische Nationalnorm: Limit for the removable surface powder and water-extractable protein of medical gloves. Branchencluster: Elektronik. Schwerpunkt: Produktsicherheit. Inkrafttreten: 1. Okt. 2010.

Die Anwendbarkeit hängt vom Produktumfang, dem Zertifizierungsweg, Bekanntmachungen der Behörden und Übergangsregeln ab. Fordern Sie eine Übersetzung an oder prüfen Sie die Quelle, bevor Sie diesen Eintrag für Compliance-Entscheidungen nutzen.

Compliance-Überblick

Dieser Überblick ist derzeit nur auf Englisch verfügbar.

Geltungsbereich und Anwendbarkeit

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.

Technische Anforderungen

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.

Prüfverfahren

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.

Häufige Fragen

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.

Hinweise zur Anwendbarkeit

Normtyp: Sicherheit
CCS: G45
ICS: 83.140.99
Zuständige Behörde: Ministry of Industry and Information Technology
Technisches Komitee: Ministry of Industry and Information Technology

Normbeziehungen

Ersetzt durch:GB 24788-2025 (Kommend)