ISO/TC 45/SC 4/WG 5 - Gloves and other latex products

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.

This document specifies the physical requirements and sampling and testing methods for single-use rubber gloves, made from natural rubber latex, synthetic rubber latex or rubber solution, intended for general applications, but not gloves intended for medical purposes. It does not cover the safe and proper usage of the gloves.

This document specifies requirements for packaged sterile, or bulked non-sterile, rubber gloves intended for use in medical examinations and diagnostic or therapeutic procedures to protect the patient and the user from cross-contamination. It also covers rubber gloves intended for use in handling contaminated medical materials and gloves with smooth surfaces or with textured surfaces over all or part of the glove. This document is intended as a reference for the performance and safety of rubber examination gloves. It does not cover the safe and proper usage of examination gloves and sterilization procedures with subsequent handling, packaging and storage procedures.

This document specifies the specification for ISO Class 4, ISO Class 5 and ISO Class 6 nitrile cleanroom gloves. It is applicable to cleanroom gloves made of acrylonitrile butadiene material.

ISO 17717:2017 specifies the minimum requirements and test methods for meteorological balloons made from natural rubber latex or natural rubber latex compounded with synthetic rubber emulsion. ISO 17717:2017 applies to two types of balloon: - Type 1: meteorological balloon produced by dipping process; - Type 2: meteorological balloon produced by moulding process.

ISO 20437:2017 gives the specification for ISO 4, ISO 5 and ISO 6 cleanroom gloves. It is applicable to cleanroom gloves made of natural rubber latex (NRL).

ISO 14285:2014 specifies limits for extractable chemical substances for single-use gloves made from natural rubber, synthetic rubber, or plastic materials that are intended for use in food preparation, food handling, and related application in food service industry. ISO 14285:2014 does not cover the specification for extractable biological substances and physical requirements of the gloves. It is not applicable to gloves used under extreme conditions such as those having pH less than 4,5 and/or temperature above 40 °C. It does not cover gloves being exposed to fat and oil foods.

ISO 11193-2:2006 specifies requirements for packaged sterile, or bulked non-sterile, poly(vinyl chloride) gloves intended for use in medical examinations, and diagnostic or therapeutic procedures, to protect the patient and the user from cross-contamination. It also covers poly(vinyl chloride) gloves intended for use in handling contaminated medical materials. ISO 11193-2:2006 is intended as a reference for the performance and safety of poly(vinyl chloride) examination gloves. The safe and proper usage of examination gloves and sterilization procedures with subsequent handling, packaging and storage procedures are outside the scope of ISO 11193-2:2006.

ISO 21171:2006 specifies methods for the determination of readily removable powder on the surface of gloves for medical use. Three methods are specified: method A for powdered gloves and methods B and C for powder-free gloves. This International Standard does not address safety issues that may be associated with the presence of powder on gloves nor does it prescribe limits on the amounts that may be present. The applicability of this International Standard to medical gloves not made from rubber has not been established.

ISO 10282:2014 specifies requirements for packaged sterile rubber gloves intended for use in surgical procedures to protect the patient and the user from cross-contamination. It is applicable to single-use gloves that are worn once and then discarded. It does not apply to examination or procedure gloves. It covers gloves with smooth surfaces and gloves with textured surfaces over part or the whole glove. ISO 10282:2014 is intended as 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 ISO 10282:2014.

ISO 25518:2009 specifies the physical requirements and methods of sampling and testing for single-use rubber gloves, made from natural rubber latex, synthetic rubber latex or rubber solution, intended for general applications. It does not cover the safe and proper usage of the gloves.

ISO 11193-1:2008 specifies requirements for packaged sterile, or bulked non-sterile, rubber gloves intended for use in medical examinations and diagnostic or therapeutic procedures to protect the patient and the user from cross-contamination. It also covers rubber gloves intended for use in handling contaminated medical materials and gloves with smooth surfaces or with textured surfaces over all or part of the glove. This part of ISO 11193 is intended as a reference for the performance and safety of rubber examination gloves. It does not cover the safe and proper usage of examination gloves and sterilization procedures with subsequent handling, packaging and storage procedures.

ISO 11193-1 specifies requirements for packaged sterile, or bulked non-sterile, rubber gloves intended for use in medical examinations and diagnostic or therapeutic procedures to protect the patient and the user from cross-contamination. It also covers rubber gloves intended for use in handling contaminated medical materials and gloves with smooth surfaces or with textured surfaces over part or all of the glove. This standard is intended as a reference for the performance and safety of rubber examination gloves. The safe and proper usage of examination gloves and sterilization procedures with subsequent handling, packaging and storage procedures are outside the scope of this standard.

ISO 10282:2002 specifies requirements for packaged sterile rubber gloves intended for use in surgical procedures to protect the patient and the user from cross-contamination. It is applicable to single-use gloves that are worn once and then discarded. It does not apply to examination or procedure gloves. It covers gloves with smooth surfaces and gloves with textured surfaces over part or all of the glove. This standard is intended as 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 International Standard.

Specifies requirements for packaged sterile, or bulked non-sterile, rubber gloves intended for use in medical examinations and diagnostic or therapeutic procedures to protect the patient and the user from cross-contamination. Also covers rubber gloves intended for use in handling contaminated medical materials. Applies to single-use gloves, gloves with smooth surfaces or with textured surfaces over part or all of the glove. Does not apply to gloves made from plastic film either of a dipped or welded construction or as a substitute for gloves for use in surgical procedures. Intended as a reference for the performance and safety of rubber examination gloves.

Specifies requirements for packaged sterile gloves intended for use in surgical procedures to protect the patient and the user from cross-contamination. Applicable to single-use gloves that are worn once and then discarded. Does not apply to examination or procedure gloves. Intended as a reference for the performance and safety of rubber surgical gloves.