单用无菌外科橡胶手套的规范

[中文适用范围]： 本文件规定了用于外科手术的包装无菌橡胶手套的要求，以保护患者和用户免受交叉污染。 本文件适用于佩戴一次后丢弃的一次性手套。 它不适用于检查或手术手套。 本文件涵盖了光滑表面的手套和部分或整个手套上有纹理表面的手套。 本文件旨在为橡胶手术手套的性能和安全性提供参考。 手术手套的安全和正确使用以及灭菌程序以及随后的处理、包装和储存程序不属于本文件的范围。 [外文原描述]： This document specifies requirements for packaged sterile rubber gloves intended for use in surgical procedures to protect the patient and the user from cross-contamination. This document is applicable to single-use gloves that are worn once and then discarded. It does not apply to examination or procedure gloves. This document covers gloves with smooth surfaces and gloves with textured surfaces over part or the whole glove. This document is intended to be a reference for the performance and safety of rubber surgical gloves. The safe and proper usage of surgical gloves and sterilization procedures with subsequent handling, packaging and storage procedures are outside the scope of this document.