This mask type is registered with Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP). JAZMP is also conducting audits at production site of these masks in Kranj, Slovenia with the aim to make sure that on the market there are only quality medical masks available which are not dangerous for wearer.
All Hygimedic medical masks or protection masks are produced according high biological safety in mind. All masks are made according standard EN 14683:2019+AC:2019 and according to medical device directive 93/42/EEC. Medical masks are packed in 50 pieces per box.
Protection masks type IIR are 3-ply medical masks, surgical mask shape, with elastic ear loops and outer layer in blue colour. They cover mouth and nose, filter air and prevent certain particles from entering respiratory tract. Protection masks type IIR are splash resistant to splash of human liquids with pressure up to 16kPa.
These face masks prevent viruses from spreading around with high BFE over 98%. Hygimedic protection masks type IIR are also water repellent.
Medical masks type IIR are single use, non sterile medical devices. According to standard EN 14683:2019+AC:2019 these type of face masks have been designed for medical personnel in hospitals and other medical institutions.