Medical surgeon and examination gloves need to be able to exhibit a minimum strength, possess barrier protection against microorganisms during use and fit the user correctly. They should also be safe for the user to wear and have a reasonable shelf life.
It is becoming common practise for procurement bodies to request independent test reports stating compliance with EN 455 from ISO 17025 accredited laboratories. Independent testing can demonstrate that medical gloves meet the appropriate performance requirements.
The SMTL are able to test nitrile, latex and vinyl examination and surgical gloves for the following characteristics:
BS EN 455-1 - Medical gloves for single use: Requirements and testing for freedom from holes
- Watertightness testing for detection of holes (UKAS accredited)
BS EN 455-2 - Medical gloves for single use: Requirements and testing for physical properties
- Dimensions (UKAS accredited)
- Force at break (UKAS accredited)
- Force at break after challenge testing (UKAS accredited)
- Labelling (UKAS accredited)
BS EN 455-3 - Medical gloves for single use: Requirements and testing for biological evaluation
- Endotoxin (UKAS accredited)
- Total extractable Protein (UKAS accredited)
- Removable Surface Powder (UKAS accredited)
BS EN 455-4 - Medical gloves for single use. Requirements and testing for shelf life determination
- Real-time shelf life determination
- Accelerated shelf life determination
BS EN ISO 21171 2006 - Medical gloves. Determination of removable surface powder
- Removable surface powder
SMTL in-house developed test methods
- Bacterial/Viral Barrier Testing
FAQ: Medical gloves, protein testing, and latex allergy
What does the modified Lowry protein test detect ?
The modified Lowry protein assay detects levels of water soluble proteins in the gloves under test. An assumption is made with this test that the level of protein detected correlates with the likelihood of the glove producing an immediate (Type I) hypersensitivity reaction in a user or patient. This test method is currently used as the soluble protein assay for European standard EN-455 Part 3.
SMTL are UKAS accredited for this test.
Why does SMTL recommend testing 4 gloves from each batch?
In the manufacture of surgical and examination glove lots, it is normal to process the left-hand and right-hand gloves separately and then pair these up at a final air-test and visual examination stage that immediately precedes placing the gloves in the final pack. Thus, the actual hour of manufacture may differ by 12 hours or more between left and right-hand gloves in a lot. In addition, manufacturing conditions can vary throughout a batch, and thus the results from a single sample will not necessarily reflect the level of protein throughout a batch.
SMTL (in association with an independent rubber consultant) therefore suggest that, for initial assessment of gloves from any company for measurement of protein, two left and two-right hand gloves should be taken from a single nominal lot (4 samples for Examination gloves).
Whilst these sample sizes are not statistically significant, SMTL believe it is a pragmatic compromise between the cost of testing and useful test data.
SMTL will, of course, carry out single sample testing if required, with a consequent reduction in testing costs.
If you wish to commission testing of your surgeons or examination gloves, then contact the SMTL:
Surgical Materials Testing Laboratory, Princess of Wales Hospital, Coity Road, Bridgend, UK, CF31 1RQ.
Tel: +44 (0) 1656 752820