GLOVES, GYNAECOLOGICAL, latex, s.u., sterile, pair, 8.5
STD
SMSUGLOG8--
Valid Article
Account code:
60210
HS Code:
401512
Last Updated on:
23/09/2024, 15:17:23
Former
Code(s):
-X
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.
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.
GYNAECOLOGICAL GLOVES, latex
Definition
Pair of sterile surgical gloves with long cuff used in gynaecology and obstetrics to protect both patient and staff from infections transmitted through contact with the hands.
Specifications
Quality Standards Comment
Technical specifications
- Natural latex, non powdered
- Anatomically-shaped: 1 right hand and 1 left hand
- Extra long cuff, elbow length, beaded
- Low residual extractable protein level, < 50µg/dm²
- Sterile, for single use
Size | Minimum Length | Palm Width |
6.5 | 450 mm | 83 ± 5 mm |
7.5 | 450 mm | 95 ± 5 mm |
8.5 | 450 mm | 108 ± 6 mm |
Packaging & Labelling
Sterile packaging per pair, in a peel-open pack.
After opening of the package, the gynaecological gloves are presented in a field, 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 gloves"
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
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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