SHOE COVER, non-woven, s.u.

STD ELINSHOC001

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).
T0208 - Shoe covers (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.
The order of this product needs to be justified and is only acceptable under certain conditions.
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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SHOE COVER

Definition

A non-sterile device made of a non-conductive material intended to be used as a physical barrier on a shoe to prevent cross-contamination between the shoe and the environment. This is a single-use device.

Specifications

Technical specifications

  • Disposable
  • Non-woven
  • Universal size
  • Ambidextrous design
  • Elastic in hem at ankle
  • Waterproof

Packaging & Labelling

Box of 200, 400 or 500 pieces

Instructions for use

Any protective clothing used in the BSL3 must not be worn in the other areas of the laboratory.

Waste management

After use discard into the waste container for infectious substances.

MSF requirements

The use of shoe covers is optional. It can be adopted as an additional protective measure in the BSL3 (Biosafety level 3 is commonly used for research and diagnostic work involving various microbes which can be transmitted by aerosols and/or cause severe disease).

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