The medical device is a bag to which ties are attached to keep the device on the user.
The medical device is worn over the shoe and then the ties are tied at the back of the shin.
The materials used to manufacture the shoe covers comply with the requirements of the applicable standards and technical specifications specified in the documentation set:
Version 1: the shoe covers consist of (surface density (in g/m2)): 40-60 g/m2 non-woven hydrophobic material made of 100% polypropylene Spunbond, Spunbond brand, manufacturer KBK Polymer Company, KBK-Torg Ltd.
Version 2: shoe covers consist of (surface density (in g/m2): 41.5 g/m2 to 58 g/m2 non-woven material made of 100% Tyvek high-density polyethylene, Tyvek brand, manufactured by DuPont de Nemours, Inc.
The shoe covers are manufactured in the following dimensions (A x H x C): 30 x 50 x 39 mm (±2 cm).
The ties are attached at the front and have the following dimensions: 400×50×3 mm (±10%).
Weight of the shoe coversNo more than 1.0 kg
Surface of the ba...
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