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

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 the front from middle of neckline to bottom): 130 – 136cm
Width or circumference (measured at the waist): minimum of 135-140 cm
Sleeves finished with double layer cuff, cotton or synthetic, stretchy interlocked jersey, length: 4 - 8 cm
Sterile
Single-use, disposable
Size: M

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