GLOVE, EXAMINATION, nitrile.,extended cuff, s.u.,non ster, L
STD
SPPEGLENEL-
Valid Article
Account code:
60210
HS Code:
401512
Last Updated on:
07/11/2024, 16:20:20
Former
Code(s):
SMSUZBE0075 SMSUZFR0059 SMSUGLEN2L- SMSUGLENEBOL SPPEEL-
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).
T01020204 - Nitrile examination / treatment 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.
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
Thermosensitive codes are defined for storage and transportation temperature requirements of the products.
GLOVE EXAMINATION, nitrile, extended cuff
Definition
Disposable and non-sterile gloves are used to protect both patient, staff and environment from cross-contamination after handling infectious substances.
Synonym
protective glove, procedure glove
Specifications
Quality Standards Comment
See SMSU: Medical GLOVES: types and uses
Technical specifications
- 100% nitrile, non powdered
- Ambidextrous shape (fits either hand)
- Thickness at fingers: max 0.1 mm
- Cuff: extended with straight edge
- Colour : blue or purple
- Non sterile, for single use
3 sizes: small (S), medium (M) and large (L)
Size | Minimum length | Palm width |
small | 290 mm | 80 ± 10 mm |
medium | 290 mm | 95 ± 10 mm |
large | 290 mm | 110 ± 10 mm |
Packaging & Labelling
Cardboard distribution box of 50 or 100 gloves.
The labelling must carry the following information: "non powdered glove".
Instructions for use
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Precautions for Use
- Discard defective or deteriorated gloves.
- Remove and replace gloves which are damaged while in use.
- Carefully follow undressing procedure when gloves are removed.
- Once removed, the gloves should be disposed of according to waste management rules. Never reuse.
Storage
- Store below 30°C, Protect from sunlight ‐ Protect from humidity
- In the original packaging
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