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GLOVES, GYNAECOLOGICAL, latex, s.u., sterile, pair, 6.5

https://unicat.msf.org/cat/product/19024
STD SMSUGLOG6--

Valid Article

Former Code(s): -X
The product is supplied (and stored) sterile, it must remain sterile until its use. Sterile = state of being free from all living microorganisms.
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).
CE marking: declaration that the product meets EU standards for health, safety, and environmental protection. The CE marking indicates that the product may be sold freely in any part of the European Economic Area, regardless of its country of origin.
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.
IIa
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
CT30
Thermosensitive codes are defined for storage and transportation temperature requirements of the products.
OC subscriptions: included in supply or field order tools (e.g. UniField)
SC subscriptions: included in supply or field tools
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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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

See: Medical GLOVES: types and uses

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
SizeMinimum LengthPalm Width
6.5450 mm83 ± 5 mm
7.5450 mm95 ± 5 mm
8.5450 mm108 ± 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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