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Materials: |
Latex: one pair of powdered latex gloves: 1 right-handed, 1 left-handed. |
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Powder: maize starch. |
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Specifications: |
Same as for surgical gloves (refer to MMREGLOVS… for more details). |
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Waterproof |
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Stretch-proof |
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Appropriate extension to rupture. |
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Straight sleeves with reinforced hem (rolled or ending in a reinforced band). |
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Suppleness: |
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- Closely fits the morphology of the hand, minimally impairing the wearer’s sense of touch. |
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- The shape of the glove accurately accommodates the anatomy of the hand; the thumb is offset from the palm and set forward of the index finger. |
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The interior surface of the gloves must be finely coated with a powder for ease of wearing. |
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- Size 6.5: minimum length 500mm, width 83 +/- 5mm |
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- Size 7.5: minimum length 500mm, width 95 +/- 5mm |
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- Size 8.5: minimum length 500mm, width 108 +/- 6mm |
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Unit presentation: |
One (1) pair or surgical gloves, sterile, individually peel packed. |
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Gloves must be supplied with double packaging: the interior layer in a peel pack. |
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Interior layer: |
Right- and left-handed gloves must be packed with their sleeves rolled up to the thumb (exposing the reverse side of each cuff). |
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Label: size, right-hand, left-hand and position of the sleeves. |
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Initial sterilization method: |
Ethylene oxide gas or gamma radiation |
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Packaging and labelling |
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Primary packaging: |
Indicate: Manufacturer’s name and address, product description, size, "sterile" with sterilization method, lot number, expiry date by year and month, "for single use", and CE mark and reference number of notifying body. Must be multilingual: English, French and Spanish, others when available. |
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Secondary packaging: |
Protected unit, one (1) box with 50 pairs of obstetrical gloves. Labelling, secondary packaging: same as the primary packaging. |
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Additional required information: Number of units per secondary packaging. Information for product-specific storage conditions (e.g., temperature, pressure, light, humidity, etc.). |
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Outer packaging: |
Packaging unit: strong carton |
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Other requirement: |
Must comply with European Medical Device Directive 92/42/EEC or equivalent international norm |
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Meets standards: |
EN 455-1:2000: Medical gloves for single use – |
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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 |