Shoe cover,non-woven,s.u.,BOX-100

General Description:
Shoe cover, non-woven, single use, box of 100

Intended use:
Shoe cover to prevent cross-contamination between the shoe and the environment. Single use only.

Technical specifications:
Shoe cover
Material: polyethylene
Elasticated opening
Preferably latex Free
Waterproof
Universal size
Fits either foot (ambidextrous)
With or without anti-slip sole
Colour: blue or white
Non sterile
Single use
Shelf life: 5 years

Environmental conditions:
Keep in clean and dry places. Store at room temperature.
Protect from heat and moisture. Do not expose to direct light or ozone.

Packaging and labelling:
Primary packaging: Unit of use
One (1) box of 100 units

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

Regulation & classification:
Medical Device Regulation (EU) 2017/745, Class I or
Personal Protective Equipment Regulation (EU) 2016/425, Category I