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GLOVES, SURGICAL, neoprene, s.u., sterile, pair, 8

https://unicat.msf.org/cat/product/65437
STD SMSUGLOSNE80

Valid Article

Former Code(s): SMSUZBD0026
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.
T01010201 - Polychloropren 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
S
The order of this product needs to be justified and is only acceptable under certain conditions.
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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GLOVES, SURGICAL, neoprene

Pair of sterile neoprene surgical gloves used in case of latex allergy to protect patient and staff from hand transmitted infections.

Neoprene gloves are a second choice and only used in cases of latex allergy.

Definition

Polychloroprene surgical glove, non-powdered
A sterile device made of polychloroprene (neoprene) intended as a protective barrier when worn on the hands of healthcare providers at the surgical site; its inner surface is not covered with powder and it does not include antimicrobial agents/materials. It is used mainly as a two-way barrier to protect patient and staff from microorganisms and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide adequate conditions of sterility, appropriate physical properties (e.g., tensile strength, resistance to puncture, elasticity), and uniformity of dimensions (i.e., sizing consistency). This is a single-use device.

Specifications

Quality Standards Comment

See: Medical GLOVES: types and uses

Technical specifications

  • Neoprene (polychloroprene)
  • Powder-free
  • Colour: green
  • Anatomical shape: 1 right hand and 1 left hand
  • In accordance with EN 455-3, the manufacturer must provide on request a list of the chemical components added during manufacture or known to be present in the product.
  • Sterile, for single-use

Packaging & Labelling

Single sterile packaging (per pair) in peelable bags.

After opening the bag, the gloves are presented in a field (which can be used as a small sterile field), cuffs turned up to the thumb to allow aseptic extraction, with left and right hand identification.

(See Introduction: Packaging and Labelling).

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

Storage

  • Store below 30°C, Protect from sunlight - Protect from humidity
  • In the original packaging

MSF requirements

Use only as a second choice in case of latex allergy. For other cases, use the SMSUGLOSxx- latex surgical glove.

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