Gloves need to be able to exhibit a minimum strength, possess barrier protection, biocompatibility and protection against microorganisms during its applications. Testing is essential to measure the performance of gloves and ensure it meets regulatory and test standards as defined by US Food and Drug Administration, American Society of Testing and Materials and international groups.
TÜV SÜD PSB works closely with non-active medical devices manufacturers and pharmaceutical manufacturers, providing reliable third party testing and inspection to international standards.
Services
Testing services for various types of gloves include:
- Medical gloves for single use
- Freedom from holes
- Dimensions
- Strength
- Leachable proteins
- Endotoxins
- Chemicals
- Rubber surgical gloves
- Freedom from holes
- Dimensions
- Tensile test
- Powder free residue
- Aqueous soluble protein content
- Antigenic protein content
- Powder amount
- Protective gloves
- Resistance to water penetration
- pH value
- Chromium (VI) content
- Extractable protein content
- Cleaning
- Electrostatic properties
- Dimensions
- Dexterity
- Water vapour transmission and absorption
- Abrasion resistance
- Blade cut resistance
- Tear resistance
- Puncture resistance
International standards that apply include:
- BS EN 455 (Medical glove)
- ISO 10282, ASTM D3577 (Surgical rubber glove)
- ISO 11193, ASTM D3578 (Rubber examination glove)
- ASTM D6319 (Nitrile examination glove)
Your advantages: |
- Reduce your business risks by meeting regulatory requirements and standards.
- Increase quality and safety of your products and processes.
- Save time and costs as we provide you with a one-stop testing and certification service.
- Take advantage of our global accreditations.
- Take advantage of our state of the art laboratories with comprehensive testing equipment and professional expertise.
- Increase customer confidence in your product when your product goes through independent testing.
- Shorten your time-to-market and increase market access when you meet regulatory requirements and standards.
- Our team is highly experienced and qualified, which adds value to your processes.
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