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GLOVE, EXAMINATION, nitrile, s.u., non sterile, M

https://unicat.msf.org/cat/product/19016
STD SMSUGLEN1M-

Valid Article

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).
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.
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.
I
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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EXAMINATION GLOVE, nitrile

Definition

Disposable 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

See: Medical GLOVES: types and uses

Technical specifications

  • 100% nitrile, non powdered
  • Ambidextrous shape (fits either hand)
  • Thickness at fingers: max 0.1 mm
  • Cuff: straight or rolled edge
  • Different colour than latex examination gloves is preferred
  • Non sterile, for single use
  • Dimensions: 3 sizes: small (S), medium (M) and large (L)
SizeMinimum lengthPalm width
small240 mm80 ± 10 mm
medium240 mm95 ± 10 mm
large240 mm110 ± 10 mm

Packaging & Labelling

Cardboard distribution box of 100, 150 or 200 gloves.

The labelling must mention: "non powdered glove".

Instructions for use

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Precautions for Use

  • STRICTLY 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
  • Once removed, the gloves should be disposed of according to waste management rules
  • For laboratory procedures in BSL2 and BSL3, the nitrile gloves with extended cuffs are recommended (see SPPE family).

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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