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.