Gown,surgic,nonsterile,nonwoven,disp,XL

General Description:
Gown, surgical, nonsterile, nonwoven, disposable, XL

Technical Specifications:
Surgical gown, with long sleeves, and a waist tie that binds at the side
Fabric, non-woven material, f.e. SMS, SMMS, etc.
Outer layer liquid penetration resistant in critical areas (chest and sleeves)
Length (measured at front from middle of neckline to bottom): 110 – 150 cm
Width or circumference (measured at waist): minimum of 150 cm
Sleeves finished with double layer cuff, cotton or synthetic, stretchy interlocked jersey, length: 4 - 8 cm
Non-sterile or sterile
Single use, disposable
Size: XL
Conform requirements of:
(a) EU Medical Devices Directive 93/42, Class I or
(b) US FDA 510(k) clearance, Class II or
(c) Equivalent internationally recognised marketing clearance
In specific, compliant with:
(a) EN 13795 standard or
(b) ANSI/AAMI PB70:2012 standard or
(c) Equivalent international standard

Packaging and labelling:
. Primary packaging is unit of use – one folded surgical gown
Labelling on primary packaging must include:
- Name and/or trademark of the manufacturer
- Manufacturer's product reference
- Type of product and main characteristics
- If the packaging is not transparent, it must bear a diagram (preferably actual size) showing the essential parts of the product and indicating the position of the product in the packaging
- Information for particular storage conditions (temperature, pressure, light, humidity, etc.), as appropriate (or equivalent harmonised symbol)
- Information for handling, if applicable (or equivalent harmonised symbol)
Over packaging: Packaging unit
Labelling on the packaging unit: Labelling to be the same as primary packaging.
Extra information required: Number of units per box.


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".

Weight: 17.5kg
Volume: 0.057m3