Definition
Pair of sterile surgical gloves used to protect both patient and staff from infections transmitted through contact with the hands.
Specifications
Quality Standards Comment
Technical specifications
- Natural latex, non powdered
- Protection 45 min to 1 h minimum
- Anatomically-shaped: 1 right hand and 1 left hand clearly identified in the packaging
- Dimensions of surgical gloves
| Size | Min. length | Width at the handpalm |
| 7.5 | 270 mm | 95 ± 5 mm |
| 8 | 270 mm | 102 ± 6 mm |
- Thickness:
- Finger: 0.19-0.24 mm
- Palm : 0.19-0.27 mm
- Cuff: 0.16-0.20 mm
- The median values of force at break for the registered results on the samples: ≥ 9N
- Freedom from holes: tested according EN455-1 (2020): AQL = 0.65
- Cuff with rolled edges
- Coated inner surface (polymere, polyurethane, silicone, …)
- Textured or micro-textured external surface
- Colour: cream - white
- Sterile, for single use
Packaging & Labelling
Unit sterile packaging (per pair) in peel-open pack.
After opening of the package, the gloves are presented in a field (that can be used as small sterile drape), the sleeves reversed up to the thumb to allow aseptic extraction, with identification of right hand and left hand.
The labelling must carry the following information:
- "(product) containing natural rubber latex which may provoke allergic reactions, such as anaphylactic shock "
- "non powdered glove"
Instructions for use
Precautions for Use
- SINGLE USE
- Wash hands before and after use of gloves
- To be worn only on dry hands
- Discard defective or deteriorated gloves.
- Remove and replace gloves which are damaged while in use
- Carefully follow undressing procedure when gloves are removed
- In case of allergy to latex, order latex-free gloves (see related articles)
Storage
- Store below 30°C, Protect from sunlight ‐ Protect from humidity
- In the original packaging