|
Components: |
One pair of slightly-powdered gloves: 1 right-handed, 1 left-handed. |
|
Materials: |
Latex |
|
|
Powder: maize starch |
|
Physical properties: |
Waterproof |
|
|
Stretch-proof |
|
|
Minimum force at break for surgical gloves: before accelerated ageing 10.5N, after accelerated ageing 7.5N. |
|
|
Straight-sleeved with reinforced hem (rolled or ending in a reinforced band). |
|
|
Moulded manufacture. |
|
|
Suppleness: Closely fits the morphology of the hand, minimally impairing the wearer’s sense of touch. 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. |
|
Slightly powdered: |
The interior surfaces of the gloves must be finely coated with powder for ease of wearing. |
|
|
Low-residual protein level (EN 455-3) |
|
|
Recommended wall thickness: |
|
|
- Finger area: 0.38mm |
|
|
- Centre palm area: 0.24-0.30mm/25mm, 0.26mm from cuff end |
|
Size: |
Minimum dimensions recommended for surgical gloves: |
|
|
- Size 6: length: 270mm, width:77, ± 5mm |
|
|
- Size 6.5: length: 270mm, width: 83, ± 5mm |
|
|
- Size 7: length: 280mm, width: 89, ± 5mm |
|
|
- Size 7.5: length: 280mm ,width: 95, ± 5mm |
|
|
- Size 8: length: 290mm, width: 102, ± 6mm |
|
|
- Size 8.5: length: 290mm, width: 108, ± 6mm |
|
|
The cuff should be long enough to cover adequately the wrist of a surgeon or nurse wearing an operating theatre gown. |
|
|
Straight-sleeved with reinforced hem (rolled or ending in a reinforced band). |
|
Unit presentation: |
One (1) pair of sterile surgical gloves, individually peel-packed. |
|
|
Gloves must be supplied with double packaging: an interior layer and a peel-off package. |
|
Interior layer: |
Gloves must be packed: in right- and left-handed pairs, with the sleeves reversed up to the thumb. |
|
|
Labelled with: size, right-hand, left-hand and the position of the sleeves. |
|
Initial sterilization method: |
Ethylene oxide gas or gamma radiation |
|
Packaging and labelling: |
Primary packaging: |
|
|
Indicate: Manufacturer’s name and address, multilingual product description (English, French and Spanish, others when available), 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. |
|
|
Secondary packaging: |
|
|
Protected unit, one (1) box of 50 pairs of surgical gloves.
Labelling on the secondary packaging: same as primary packaging. |
|
|
Additional required information: Number of units per secondary packaging. Information for product-specific storage conditions (e.g., temperature, pressure, light, humidity, etc.). |
|
Outer packaging: |
Packaging unit: strong carton |
|
Other requirements: |
Complies with European Medical Device Directive 92/42/EEC or equivalent international norm. |
|
Meet standards: |
EN 455-1:2000: Medical gloves for single use – Part 1: Requirements and testing for freedom from holes |
|
|
EN 455-2:2000: Part 2. Requirements and testing for physical properties |
|
|
EN 455-3:2000: Part 3. Requirements and testing for biological evaluation |