GLOVE, EXAMINATION, latex, s.u. non sterile, medium
STD
SMSUGLOE1M-
Valid Article
Account code:
60210
HS Code:
401512
Last Updated on:
22/10/2024, 13:16:05
Former
Code(s):
-X SMSUZRU0009 SMSUZYN1002
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).
T010201 - Latex 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.
The product is part of at least one Kit.
A kit is a collection of products (medical and/or logistic) that are needed for a certain intervention in emergency. The choice and quantity of the articles reflects the MSF protocols for this specific situation. The use of Kits allows to start an intervention without a detailed evaluation.
EXAMINATION GLOVE, latex
Definition
Non sterile glove used to protect both patient and staff from infections transmitted through contact with the hands.
Synonym
protective glove, procedure glove
Specifications
Quality Standards Comment
Technical specifications
- Natural latex, non powdered
- Ambidextrous shape (fits either hand)
- Cuff: straight or rolled edge
- Low residual extractable protein level
- Non sterile, for single use
- Dimensions: 3 sizes: small (S), medium (M) and large (L)
Size | Minimum length | Palm width |
small | 240 mm | 80 ± 10 mm |
medium | 240 mm | 95 ± 10 mm |
large | 240 mm | 110 ± 10 mm |
Packaging & Labelling
Cardboard distribution box of 100 gloves.
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
- 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
- These gloves do not protect against physical and chemical risks which require other types of gloves
- In case of allergy to latex, order latex-free gloves such as nitrile gloves (see related articles)
Storage
- Store below 30°C, Protect from sunlight ‐ Protect from humidity
- In the original packaging
MSF requirements
Non powdered glove, allowing the use of hydroalcoholic solution as hand cleanser.
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