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GLOVES, SURGICAL, latex, s.u., sterile, pair, 8.5

https://unicat.msf.org/intros#14999
https://unicat.msf.org/cat/product/19045
STD SMSUGLOS85-

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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SURGICAL GLOVES, latex

Definition

Pair of sterile surgical gloves used 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
  • Protection 45 min to 1 h minimum
  • Anatomically-shaped: 1 right hand and 1 left hand clearly identified in the packaging
  • Dimensions of surgical gloves
SizeMin. lengthWidth at the handpalm
6260 mm77 ± 5 mm
6.5260 mm83 ± 5 mm
7270 mm89 ± 5 mm
7.5270 mm95 ± 5 mm
8270 mm102 ± 6 mm
8.5280 mm108 ± 6 mm
  • Thickness:
    • Finger: 0.19-0.24 mm
    • Palm : 0.19-0.27 mm
    • Cuff: 0.16-0.20 mm
  • The median values of force at break for the registered results on the samples: ≥ 9N
  • Freedom from holes: tested according EN455-1 (2020): AQL = 0.65
  • Cuff with rolled edges
  • Coated inner surface (polymere, polyurethane, silicone, …)
  • Textured or micro-textured external surface
  • Colour: cream - white
  • Sterile, for single use

Packaging & Labelling

Unit sterile packaging (per pair) in peel-open pack.

After opening of the package, the gloves are presented in a field (that can be used as small sterile drape), 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 glove"

Instructions for use

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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 (see related articles)

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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