Single-use Medical Poly(vinyl chloride) Examination Gloves
Warning: Persons using this standard shall be familiar with normal laboratory practices. This standard does not purport to address all of the safety problems, if any, associated with its use. It is the responsibility of the user to establish appropriate safety and health practices and to ensure compliance with any regulatory conditions.
1 Scope
This standard 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.
This standard specifies requirements for the performance and safety of single-use medical poly(vinyl chloride) examination gloves. However, 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.
This standard is applicable to single-use medical poly(vinyl chloride) examination gloves for use in medical examinations, diagnosis or treatment of patients and handling contaminated medical materials.
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 (excluding corrections), or revisions, of any of these publications do not apply to this standard. 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 528 Rubber, Vulcanized or Thermoplastic — Determination of Tensile Stress-strain Properties (GB/T 528-2009, ISO 37:2005, IDT)
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)
GB/T 2941-2006 Rubber — General Procedures for Preparing and Conditioning Test Pieces for Physical Test Methods (ISO 23529:2004, IDT)
GB/T 3512 Rubber, Vulcanized or Thermoplastic — Accelerated Ageing and Heat Resistance Tests — Air-oven Method (GB/T 3512-2001, eqv ISO 188:1998)
GB/T 16886 (all parts) Biological Evaluation of Medical Devices [ISO 10993 (all parts), IDT]
YY 0466-2003 Medical Devices — Symbols to be Used with Medical Device Labels, Marking and Information to be Supplied (ISO 15223:2000, IDT)
3 Classification
Gloves are classified by finish as follows:
a) textured surface over part or all of the glove;
Foreword II
1 Scope
2 Normative References
3 Classification
4 Material
5 Sampling and Selection of Test Pieces
6 Requirements
7 Packaging
8 Marking
Annex A (Normative) Watertightness
