Device Dossier

Synthetic-polymer liquid barrier dressing, non-sterile

Device Dossier for Synthetic-polymer liquid barrier dressing, non-sterile (Synthetic-polymer liquid barrier dressing, non-sterile, Class IIa, sponsor…

Intended purpose

A device 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, fluids, adhesive dressings, drainage tubes, external catheters, and surrounding ostomy sites. It can also be used on heels, elbows and other areas of the body that are at risk of irritation due to friction damage caused by external surfaces such as linens and mattresses. The product may be used on adults, children, and full-term infants from one month.

TGA Public Summary