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: XL
. 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)