Single-use Medical Rubber Examination Gloves
1 Scope
This 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 crosscontamination. 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.
2 Normative References
The following normative documents contain provisions which, through reference in this text, constitute provisions of this standard. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this standard are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applies.
GB/T 2828.1 Sampling Procedures for Inspection by Attributes — Part 1: Sampling Schemes Indexed by Acceptance Quality Limit (AQL) for Lot-by-lot Inspection (GB/T 2828.1-2003, ISO 2859-1:1999, IDT)
YY/T 0466 Medical Devices — Symbols to be Used with Medical Device Labels, Labelling and Information to be Supplied
ISO 37 Rubber, Vulcanized or Thermoplastic — Determination of Tensile Stress-strain Properties
ISO 188 Rubber, Vulcanized or Thermoplastic — Accelerated Ageing and Heat Resistance Tests
ISO 4648 Rubber, Vulcanized or Thermoplastic — Determination of Dimensions of Test Pieces and Products for Test Purposes
ISO 10993 (all parts) Biological Evaluation of Medical Devices
3 Classification
3.1 General
Gloves are classified by type and finish, as given in 3.2 and 3.3.
Foreword II
1 Scope
2 Normative References
3 Classification
4 Materials
5 Sampling and Selection of Test Pieces
6 Requirements
7 Packaging
8 Marking
Annex A (Normative) Test for Watertightness
