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: L
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 (in the standard or high performance category) or
(b) ANSI/AAMI PB70:2012 standard (in the AAMI Level 3 or AAMI Level 4 category) or
(c) Equivalent international standard