GLOVES, SURGICAL, latex, s.u., sterile, pair, 6
STD
SMSUGLOS60-
Valid Article
Account code:
60210
HS Code:
401512
Last Updated on:
22/10/2024, 12:56:33
Former
Code(s):
SMSUZBD0041 SMSUZNL0066
Single use
A single-use device, also referred to as a disposable device, is intended for use on one patient during a single procedure. It is not intended to be reprocessed (i.e., cleaned and disinfected or sterilized).
T01010102 - Non-powdered latex surgical gloves
European Medical Device Nomenclature (EMDN) is the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database. EMDN is characterised by its alphanumeric structure that is established in a seven-level hierarchical tree.
OC subscriptions: included in supply or field order tools (e.g. UniField)
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SC subscriptions: included in supply or field tools
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OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)
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SURGICAL GLOVES, latex
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 |
| 6 | 260 mm | 77 ± 5 mm |
| 6.5 | 260 mm | 83 ± 5 mm |
| 7 | 270 mm | 89 ± 5 mm |
| 7.5 | 270 mm | 95 ± 5 mm |
| 8 | 270 mm | 102 ± 6 mm |
| 8.5 | 280 mm | 108 ± 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
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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
MSF requirements
Non powdered gloves, allowing the use of hydroalcoholic solution as hand cleanser
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