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Components: |
Ambidextrous powdered glove composed of 5 fingers, a palm and a sleeve. |
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Materials: |
Natural latex |
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Powder: resorbable maize starch |
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Specifications: |
Ambidextrous: fits either hand |
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Meets European norm EN 455-1 |
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Watertight |
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Meets European norm EN 455-2 |
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Moulded manufacture |
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Total length: 240mm minimum |
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Width: |
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- Small: 80 ± 10mm |
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- Medium: 95 ± 10mm |
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- Large:110 ± 10mm |
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Strength: breaking force (for latex gloves): |
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- Before accelerated ageing: 7.5N |
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- After accelerated ageing: 5.5N |
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Low residual protein level (refer to EN 455-3): |
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- 250µg/g for powdered gloves |
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- 50µg/g for non-powdered gloves |
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Lengthening at break: minimum 600% |
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Cuff length: minimum 5cm |
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Strictly for single use. |
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After use, ensure complete destruction by incinerating in a protected area. |
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Storage: |
In a dry place, away from a direct heat source. |
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Packaging: |
Cardboard dispensing box with 100 gloves. |
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Labelling on the box: Manufacturer’s name and address; product name and size; manufacturing date and expiry date; and CE mark. Must be multilingual: English, French and Spanish, others when available. |
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Complies with European Norm EN 455-3: |
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Gloves that are directly derived from latex need to indicate the following: "(product) containing natural rubber latex likely to provoke allergic reactions". |
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- Powdered gloves need to bear a label specifying that they are powdered |
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Other requirements: |
Must comply with European Medical Device Directive 92/42/EEC, or equivalent international norm. |
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Meet standard: |
EN 455-1:2000: Medical gloves for single use – Part 1: Requirements and testing for freedom from holes |
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EN 455-2:2000: Part 2. Requirements and testing for physical properties |
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EN 455-3:2000: Part 3. Requirements and testing for biological evaluation |