Synthetic-polymer liquid barrier dressing, non-sterile

Intended purpose

The device is a liquid intended for use as a film-forming product that upon application to intact or damaged skin forms a long-lasting waterproof barrier, which acts as a protective interface between the skin and bodily wastes and fluids. It is intended as a primary barrier against irritation from bodily fluids and can be used on adults, children, and infants over 12 weeks old by health professionals and may be used in a hospital, community and home setting.