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APRON SURGICAL, rubber

https://unicat.msf.org/cat/product/13525
STD ELINAPRS1R-

Valid Article

Former Code(s): -X
T0209 - Surgical aprons (excluding personal protective equipment - ppe)
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.
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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APRON SURGICAL, rubber

Definition

A garment designed to be worn by surgical staff for protection from soiling or spills on the ventral (front) aspect of the body during surgical procedures. This is a reusable garment that must be cleaned / disinfected after each use.

Specifications

Quality Standards Comment

Classification according to P​PE Regulation (EU) 2016/425: Category I.

Technical specifications

  • Nitrile rubber of light colour (including back waist ties and neck strap)
    • Nitrile rubber (NBR‌ = nitrile butadiene rubber) is a synthetic rubber copolymer. The physical and chemical properties vary depending on the polymer's composition of nitrile. NBR is generally resistant to oil, fuel, and other chemicals (the more nitrile within the polymer, the higher the resistance to oils but the lower the flexibility of the material).
  • Straight bib apron, seamless, liquid proof and stain resistant
  • Long back waist ties and adjustable neck strap allowing for easy donning and doffing
  • Dimensions: 70-90 cm (width) x 120-150cm (height)
  • Good resistance to common cleaning products (chlorine, bleach, washing powder, soaps...)
  • Good resistance to tearing and perforation: thickness = 300 - 400 µm
  • No metal rings
  • Non sterile, reusable

Packaging & Labelling

Unit packaging

Instructions for use

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Precautions for Use

Inspect the apron before each use to make sure there are no strike throughs, degradation of the material and that it still protects the user from exposure to blood and body fluids as well as any cleaners and disinfectants.

Maintenance

Send to the laundry for correct processing: cleaning with soap and disinfecting with a chlorinated solution. Do not mix both.

Do not sterilise by steam autoclave.

Destroy if damaged (perforated, torn, etc.).

MSF requirements

Individual protection intended for staff performing medical-surgical procedures with high risk of infection (surgery, deliveries...).

The apron is also part of the full personal protective equipment worn in VHF contexts.

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ISO 7010 sign: Wear Apron.

Round shape, white pictogram on a blue background (the blue part must take up at least 50% of the total area of the sign).