Glove testing at the Surgical Materials Testing Laboratory.

This document describes the types of tests offered by SMTL for the testing of medical gloves (examination and surgeons).

Standards.

SMTL test medical gloves to the following standards:

BS 4005: 1996 - Single use, sterilised surgical rubber gloves.

This is a UK specific British Standard, which calls up EN 455 parts 1 and 2. It adds certain packaging and labelling requirements over and above the EN-455 tests.

SMTL are NAMAS accredited to test Surgeons gloves to this standard.

Medical gloves for Single Use - EN455-1:1994, EN455-2:1995

Together, these two standard cover requirements for medical gloves (latex or non-latex) for

Perforations
Dimensions
Force at break (before and after accelerated aging).

SMTL are NAMAS accredited to test gloves to these standards.

Medical gloves for Single Use - prEN 455-3:1996

This standard covers the biological aspects of medical gloves, including extractable protein and endotoxin testing. It is currently in draft, and is being actively debated in Europe. SMTL are NAMAS accredited to carry out protein testing of gloves to this draft standard.

Protein is important because it is the protein in latex gloves that can cause type I hypersensitivity (allergic) reactions. For more details, see the Frequent;y Asked Questions paper, or the Glove Safety paper.

Endotoxin testing is only required if the manufacturers make a claim that their gloves are low endotoxin gloves.

Cytotoxic Permeation

SMTL are now in a position to offer cytotoxic permeation testing of gloves.

The test method measures the breakthrough times for different cytotoxic drugs through the gloves under test.

If you want further information, please contact SMTL.

This site was originally set up with the aid of sponsorship from the Value for Money Unit, Welsh Office and an educational grant from Sophos Convatec.

URL: http://www.smtl.co.uk/MDRC/Gloves/Glove-Testing.html
Last Modified: Wednesday, 26-May-1999 15:07:08 BST