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SURGICAL GOWN, non-woven, high performance, sterile, XXL

https://unicat.msf.org/intros#21930
https://unicat.msf.org/cat/product/13551
STD ELINGOWSSXX

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.
T020402 - Reinforced surgical gowns
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 sterile
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
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 GOWN, HP, non-woven

Definition

A single use garment made of synthetic materials intended to be worn over a scrub suit to cover the arms, trunk, and upper legs, during a surgical procedure; it may be fluid resistant or impervious to fluids. Also known as an operating room (OR) gown, it is used during surgical procedures to help protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.

Synonym

surgical smock

Specifications

critical product area: product area with a greater probability to be involved in the transfer of infective agents to or from the wound, e.g. front and sleeves of surgical gowns

Quality standards

EN 13795-1, 2019, Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns

Quality Standards Comment

EN 13795 test results (gown high performance)

  • EN 29073-3: Tensile strength - dry and wet: ≥ 20 Newton (amount in force applied to break the strip)
  • EN 13938-1: Burst strength - dry and wet: ≥ 40 kPa strength at burst
  • EN 20811: Resistance to fluid penetration: critical area / less critical area: ≥ 100/10 cm of water pressure on the fabric sample
  • EN ISO 11737: Cleanliness – microbial: ≤ 300 Number of colonies formed / dm²
  • ISO 9073-10: Cleanliness – particulate matter and Linting: Number of particles 3-25µm as an index for PM expressed as Log10: critical area / less critical area: ≤ 3.5 / ≤ 4.0
  • ISO 22612: Resistance to microbial penetration – dry: ≤ 300 CFU (number of colonies formed after incubation)
  • ISO 22610: Resistance to microbial penetration – wet: for the critical area: ≥ 6.0 Number of colonies formed after incubation, expressed in Barrier Index

Technical specifications

  • Non-woven, multilayer (SMS or SMMS)
  • Impervious supplementary protection layer (polyethylene film, nonwoven, etc.) in the critical zones (chest area and forearms) = reinforced
  • For medium to high fluid level interventions
  • Wraparound
  • Long sleeves
  • Cuffs made of elastic jersey
  • Latex-free
  • Sterile, for single use
  • Comes in 3 sizes: Large, XLarge and XXLarge.
  • Length (shoulder seam to mid calf):
    • size Large: ± 140 cm
    • size XLarge: ± 150 cm
    • size XXLarge: ± 160 cm

Packaging & Labelling

  • Unit presentation with reverse folding in order to ensure an aseptic gowning technique
  • Wrapped in a drape
  • Double sterile packaging in peel-open pack

Instructions for use

Disposable sterile gowns are intended for situations where sterilization is problematic. It is recommended to keep a small emergency stock in every hospital.

Single use linen is MSF standard for orthopedic surgical procedures.

Surgeries at high risk (= high performance level needed):

  • any procedure in which the surgeons hands are in a body cavity
  • orthopedic procedures during which tourniquets are not used
  • open cardiovascular or thoracic procedures
  • trauma procedures
  • C-sections

Precautions for Use

According to the quality standards, the back of the surgical gown may have a low liquid penetration barrier performance: can be ANSI/AAMI-Level 1 even though the whole gown is classified as ANSI/AAMI-Level 4 surgical gown. Therefore, using a surgical gown in isolation settings may not provide appropriate protection.

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