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ISOLATION GOWN, s.u., non sterile

https://unicat.msf.org/cat/product/13548
STD ELINGOWI1--

Valid Article

Former Code(s): -X ELINZYN1015 ELINZYN1016
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.
T0205 - Non-surgical gowns (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.
I
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
tegory I - minim
Personal protective equipment: Equipment that will protect the health staff against health or safety risks in medical activities.
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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ISOLATION GOWN, single use

Definition

Non sterile single use garment intended to be worn by healthcare providers or visitors to protect the patient from the transfer of infectious agents. It may also help to protect the healthcare provider or visitor from a contagious agent which has infected the patient.

This gown has a limited liquid barrier protection but is not tested for infectious barrier properties.

Specifications

Quality standards

ISO 811, 2018, edition 2, Textiles - Determination of resistance to water penetration - Hydrostatic pressure test

Technical specifications

The isolation gown ideally should not restrict the movement of the body and should be breathable and comfortable to wear for long periods.

Non-woven materials alone or in combination with materials that offer increased protection from liquid penetration: SMS, SMMS or polyethylene-coated polypropylene, or Chlorinated polyethylene elastomers (CPE) or equivalent

  • non sterile
  • water resistant: HH rate min 200 mm (ANSI / AAMI level2)
  • breathable, flexible
  • full back gown, closure in the back
  • neck closure: 3 options
    • velcro closure (hook and loop) is preferred
    • tape tab neck closure
    • tie closure
  • waist tie that binds at the back or at the side (not in the front), the back has to be fully covered
  • long sleeves
  • cuffs at the wrists: 3 different types
    • cotton or cotton / polyester blend knit cuff
    • elastic around the wrist
    • thumb loop (last choice as it complicates hand hygiene)
  • single use
  • Universal size, but coverage of the whole upper body till under the knees required
    • length (measured at front from middle of neckline to bottom): 130 –145 cm
    • circumference (measured at waist): minimum 130 cm

Instructions for use

To be worn when there is:

  • a protection isolation of an immune-depressed patient, like burn patient, malnourished child, AIDS patient...
  • an infectious isolation: contagious diseases transmitting by airborne contact (droplets)

Follow the rules of undressing and dressing.

Precautions for Use

Ties on the abdomen or torso, if present, should be tied properly: they may cause other hazards if not tied properly or not tied at all.

In order to eliminate the strike-through through the cuffs, gloving over the cuff is strictly recommended.

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