Gown,surgic,nonster,nonwoven,STD,disp,XL

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

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

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): 135 – 145cm
Width or circumference (measured at waist): minimum of 140-146 cm
Sleeves finished with double layer cuff, cotton or synthetic, stretchy interlocked jersey, length: 4 - 8 cm
Non-sterile
Single use, disposable
Size: XL

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

Regulation & classification:
Medical Device Regulation (EU) 2017/745, Class I
Medical Device Directive 93/42/EEC, Class I
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

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".