GB/T 24787-2009Single-use non-sterile rubber surgical gloves (English PDF)

Foreword

GB/T 24787-2009 was issued on 15 December 2009 by the General Administration of Quality Supervision, Inspection and Quarantine and the Standardization Administration of the People's Republic of China, and has been in force since 1 October 2010. The /T in the designation marks it as a recommended rather than a compulsory national standard.

This is the official English translation published by openstd, the national public service platform for standards information. SAC/TC 35/SC 4 is in charge of the English translation; where the English and the Chinese differ, the Chinese original is the authoritative text.

The standard was proposed by the China Petroleum and Chemical Industry Federation and prepared by SAC/TC 35/SC 4, the Subcommittee on rubber latex products of the China National Standardization Technical Committee on Rubber and Rubber Products.

1 Scope

China's national standard for single-use rubber surgical gloves supplied non-sterile. A surgical glove is a barrier in both directions: it protects the patient from the surgeon and the surgeon from the patient, and the whole of its value rests on the film staying intact for the length of a procedure. This standard fixes the properties, the safety and the technological requirements that make that barrier trustworthy, and it does so for gloves that leave the factory in a packaged but non-sterile state, to be sterilized by the user before the operation. It classifies gloves by material - natural rubber latex, synthetic latices and solutions, or a mixture of the two - and by design, finish and separating material, so that a product can be designated unambiguously in a purchase order. It then sets the sampling scheme and acceptance quality limits for each characteristic, the palm width, length and single-wall thickness for every size code, a water-tightness test in which each glove is filled with water on a mandrel and observed for leaks, and the tensile requirements, which are checked both on fresh test pieces and after accelerated ageing, because a glove that is strong when new but degrades on the shelf offers a barrier that fails at the worst possible moment. It closes with packaging and marking, including the warnings that a natural latex product can cause allergic reactions and that the gloves must be sterilized before use. Storage, safety in use, correct usage and the sterilization procedure itself lie outside its scope.

The standard specifies the property, safety and technological requirements of single-use non-sterile rubber surgical gloves.

It applies to packaged single-use non-sterile rubber surgical gloves used in surgical procedures to protect the patient and the user from cross-contamination. Storage, safety, proper usage and the sterilization procedure with the subsequent handling of the gloves are outside its scope.

2 Normative references

For dated references, subsequent amendments excluding corrections, or revisions, do not apply; parties to agreements based on the standard are nevertheless encouraged to investigate the possibility of applying the most recent editions. For undated references the latest edition applies.

GB/T 528 Rubber, vulcanized or thermoplastic - Determination of tensile stress-strain properties

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 2941 Rubber - General procedures for preparing and conditioning test pieces for physical test methods

GB/T 3512 Rubber, vulcanized or thermoplastic - Accelerated ageing and heat resistance tests

GB/T 16886 (all parts) Biological evaluation of medical devices

YY 0466-2003 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied

3 Classification

Gloves are classified by type, design, finish and adhesive materials, and the four axes combine into a short designation: a powder-free glove of natural rubber latex with a textured surface and straight fingers, for example, is written as 1-RTF.

4 Materials

Gloves shall be manufactured from compounded natural latex, compounded polychloroprene rubber latex, compounded styrene-butadiene rubber or thermoplastic elastomer solution or emulsion, or compounded styrene-butadiene rubber emulsion. Any surface treatment, lubricant, powder or polymer coating used to ease donning is permitted subject to compliance with GB/T 16886.

Any pigment used shall be non-toxic, and substances used for surface treatment that are capable of being transferred shall be bio-absorbable.

Gloves as supplied to the user shall comply with the relevant parts of GB/T 16886, and the manufacturer shall make the supporting data available to the purchaser on request.

5 Sampling and selection of test pieces

Gloves shall be sampled and inspected in accordance with GB/T 2828.1, using the inspection levels and acceptance quality limits given in Table 1 for the characteristics listed there - physical dimensions, water-tightness, and the tensile properties before and after accelerated ageing. Where a lot size cannot be determined, a lot of 35 001 pairs to 150 000 pairs is assumed.

Where test pieces are required they shall be taken from the palm or the back of the gloves, along the dip direction.

7 Packaging

Gloves shall be packaged in an appropriate manner.

A Annex A (normative) Test for water-tightness

The glove is attached to a circular hollow mandrel of at least 60 mm external diameter by a suitable device such as an O-ring, so that it does not extend more than 40 mm over the mandrel, and is held vertically in a holding device.

A measured volume of 1 000 mL of water at a maximum temperature of 36 degrees C is introduced into the mandrel and any water splashed on to the glove is removed. Leaks that are immediately evident are noted; if the glove does not leak immediately, a second observation is made two to four minutes after pouring. Leakage within 40 mm of the cuff end is disregarded, and the water may be coloured with a water-soluble dye to make observation easier.