Isolation gown, with long sleeves and a waist tie that binds at the back or front
– Fabric, non-woven material, f.e. SMS, SMMS, polyethylene-coated polypropylene, etc.
Outer layer viral penetration resistant material in critical areas (full front and arms) that is infective agent tested against viral penetration at a minimum pressure of 1.75kPa
– In specific, the material passes a test for resistance to penetration by blood-borne pathogens such as:
(a) ISO 16604:2004, at Class 2 or higher or
(b) ASTM F1671 or
(c) Equivalent international standard
– Minimum average material density: 20 g/m2
– Length (measured at front from middle of neckline to bottom): 110 – 150 cm
– Width or circumference (measured at waist): minimum of 130 cm
– Sleeves finished with double layer cuff, cotton or synthetic, stretchy interlocked jersey, length: 4 – 8 cm
– Non-sterile
– Single use, disposable
– Size: L
– Conform requirements of EU Medical Devices Directive 93/42, Class I (or equivalent internationally recognised marketing clearance) and/or EU Personal Protective Equipment Directive 89/686, Category I (or equivalent internationally recognised marketing clearance)