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 は現行の中国強制国家規格です：Limit for the removable surface powder and water-extractable protein of medical gloves。業界：電子。テーマ：製品安全。施行日：2010年10月1日。

適用可否は製品範囲、認証ルート、所管当局の通知、移行規定によって異なります。コンプライアンス判断に使う前に、翻訳をご依頼いただくか公式情報源をご確認ください。

コンプライアンス概要

この概要は現在英語のみで提供しています。

適用範囲

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.

技術要求

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.

試験方法

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.

よくある質問

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.

適用のヒント

種別: 安全
CCS: G45
ICS: 83.140.99
所管部門: Ministry of Industry and Information Technology
技術委員会: Ministry of Industry and Information Technology