Manufacturer ISO 9001:2000 & ISO 13485:2001 accredited
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Quality assurance programs at all stages of production to ensure against defects
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Documentation available on request
Environmental controls to limit any airborne contamination during manufacture
Lot numbers allocated to every box of gloves
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Allows for traceability and accountability for each production batch
Every container of latex gloves that Fine Touch Disposables imports is quality tested to the AS/NZS 4011 Standard (Specification for single use examination gloves)
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Quality test results available for stock in the warehouse at any time
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Documentation available on request
Quality Standards
Oon latex gloves, powdered & powder free
EXCEED ALL requirements of:
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ASTM D3578 American Standard (Specification for rubber examination gloves)
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EN 455 European Standard (Medical gloves for single use)
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FDA 510K (USA pre market notification for Class 1 medical devices)
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CE Marking (compliance with European Standards)
COMPLY WITH ALL requirements of:
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EEC Directive 90 / 128 / EEC for foodstuffs
Suitable for contact with Animal Products, Milk Products, Fruit & Vegetables, Bakery Products, Confectionery, Beverages
Documentation available on request
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US Code of Federal Regulations, Title 21, Part 177.2600
Documentation available on request
BEEN NOTIFIED on the New Zealand MEDSAFE database for Medical Devices:
