These non-sterile compresses with a folded-over cut edge are made from 17-thread gauze. They are used for general first aid of wounds, wound cleansing, wound covering, and absorption of blood and bodily fluids. The gauze compresses are intended for single use and must be sterilized before application to open wounds using a validated method (moist heat according to DIN EN ISO 17665, radiation according to DIN EN ISO 11137, or ethylene oxide according to DIN EN ISO 11135).

Contraindications

There are no known contraindications, unless there is an allergy to cotton.

Normative and legal requirements

The gauze compresses are Class I medical devices, Rule 4 according to the German Medical Devices Act (MPG), Directive 93/42/EEC, and the Medical Device Regulation (EU) 2017/745. The gauze compresses meet the requirements of DIN EN 14079. According to the European standard EN ISO 10993-1 "Biological evaluation of medical devices," the gauze compresses are medical devices that come into contact with body surfaces (skin and mucous membranes) and are classified as having a contact duration of A (less than 24 hours). The product does not contain any hazardous toxic substances as defined by REACH. It bears CE marking and DIN EN ISO 15223-1 and EN 1041 markings on all packaging stages.

Pharmaceutical registration numbers (PZN)

Technical data