Gown,surgic,sterile,nonwoven,STD,disp,L

General Description:
Gown, surgical, sterile, non-woven, disposable, L

Intended Use:
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 to protect skin and prevent soiling of clothing during activities that are likely to generate splashes or spray of blood, body fluids or secretion, and excretions.

Technical Specifications:
Surgical gown, with long sleeves to be used in healthcare facilities.
Waist tie that binds at the side.
Material: synthetic nonwoven material
Fabric-reinforced on front side and sleeves for moderate to high fluid contact.
Outer layer liquid penetration resistant in critical areas (chest and sleeves)
Sleeves finished with cotton/synthetic mix double layer cuff.
Length (measured at front from middle of neckline to bottom): 130 – 136cm
Width or circumference (measured at waist): minimum of 135-140 cm
Disposable.
Single use.
Sterile.

Quality Management System:
ISO 13485:2016: Medical devices - Quality management systems

Regulation & classification:
Medical Device Regulation (EU) 2017/745, Class I sterile
Medical Device Directive 93/42/EEC, Class I sterile
US FDA 510(k) clearance, Class II or
Equivalent internationally recognised marketing clearance

Compliance to safety & product performance standards:
AAMI PB70 and ASTM F2407
EN 13795
EN 13034 - Type PB [6] (stitched gown), with minimum hydrostatic head of 50 cmH2O
EN 556

Instructions for use:
Wear to protect skin and prevent soiling of clothing during activities that are like to generate splashes or spray of blood, body fluids or secretion, and excretions.

Remove soiled gown as soon as possible and perform hand hygiene.

Safety process:
If the surgical gown is damaged (perforation, etc.), it must be disposed in waste container, collected and destroyed. Please refer to WHO publication "Safe management of waste for Health Care".