GLOVE, EXAMINATION, nitrile.,extended cuff, s.u.,non ster, L

STD SPPEGLENEL-

Valid Article

Former Code(s): SMSUGLEN2L- SPPEEL- SMSUMISC059 SMSUZFR0059 SMSUGLENEBOL SMSUZBE0075
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.
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
The order of this product needs to be justified and is only acceptable under certain conditions.
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.
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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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

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)

SizeMinimum lengthPalm width
small290 mm80 ± 10 mm
medium290 mm95 ± 10 mm
large290 mm110 ± 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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