Single-use sterile rubber surgical gloves

Single-use sterile rubber surgical gloves- (abstract from ISO 10282:2002) 

1 Scope

This international Standard 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.

2 Classification

2.1 Type

Two types are classified:

a) Type 1: gloves made primarily from natural rubber latex;

b) Type 2: gloves made primarily from nitrile rubber latex, polychloroprene rubber latex, styrene-butadiene rubber solution, styrene-butadiene rubber emulsion or thermoplastic elastomer solution.

2.2 Design

Two designs are classified:

a) gloves with straight fingers;  b) Gloves with fingers curved in the palmar direction.

The glove shall be anatomically correct, with the thumb positioned towards the palmar surface of the index finger rather than lying flat. The fingers and thumb may be straight or curved in the palmar direction.

2.3 Finish

Four finishes are classified:

a) Textured surface over part or all of the glove;  b) Smooth surface

c) Powdered surface;  d) Powder-free surface.

Note 1 Powdered gloves are gloves where a powder has been added as a part of the manufacturing process, generally to facilitate donning. Powder-free gloves are gloves which have been manufactured without the deliberate addition of powdered materials to facilitate donning.

Note 2: The cuff termination of the glove may be cut or in the form of a rolled rim.

3 Sampling and selection of test pieces

3.1 Sampling

For reference purposes, gloves shall be sampled and inspected in accordance with ISO 2859-1. The inspection levels and acceptable quality limits(AQLs) shall conform to those specified in Table 1 for the characteristics listed. When a lot size cannot be determined, a lot of 35001 to 50 000 shall be assumed.

Table 1 – Inspection levels and AQLs