Gown,isolation,nonwoven,disp,L

General Description:
Gown, isolation, non-woven, disposable, size L

Intended Use:
To protect the healthcare worker/patients’ skin and prevent soiling or contamination of clothing during procedures and patient-care activities.

Technical specifications:
Isolation gown, with long sleeves, a waist tie that binds at the back or front
Fabric, non-woven material, f.e. SMS, SMMS, polyethylene-coated polypropylene, etc.
Outer layer liquid penetration resistant in critical areas (full front and arms)
Minimum average material density: 30 g/m2
Length (measured at front from middle of neckline to bottom): 130 – 136cm
Width or circumference (measured at waist): minimum of 135 - 140 cm
Sleeves finished with double layer cuff, cotton or synthetic, stretchy interlocked jersey, length: 4 - 8 cm
Non-sterile
Single use, disposable
Size L

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 (Level 1–3) and ASTM F3352
EN 13034 - Type PB [6] (stitched gown), with minimum hydrostatic head of 50 cmH2O
AAMI PB70 Level 4 and ASTM F3352 or
ISO 16604 Class 5
Or alternative equivalent set of standards

Packaging and labelling:
Packaging: 1 pcs. / bag