Characteristics :
- Type II single-use 3-ply masks are intended to trap particles and aerosols of respiratory flows (saliva, secretions, etc.) emitted by the person wearing the mask while allowing them to breathe without difficulty.
- They have a long nose strip which helps keep them on the nose and limits fogging.
- The elastic bands, ear loops, are round and free of latex.
Indication:
- Type II medical masks are recommended to protect both healthcare professionals and patients from the transfer of microorganisms.
- They also allow, with their waterproof external face, to protect against possible projections during surgical procedures in the operating room.
Labeling:
- On each packaging unit are written the reference, the lot number and the expiration date,
- Symbols used in accordance with standard EN ISO 15223-1: Symbols used for the labelling of medical devices.
Conformity :
MEDICAL DEVICE
Class I : 93/42 EEC Directive & 2007/47 EEC Directive
EN 14683 + AC (2019) Single Use Medical Masks —Test requirements and methods
EN 10993-1 Biocompatibility general requirements
EN 10993-5 Biocompatibility in vitro cytotoxicity
EN10993– 10 Biocompatibility sensitization and skin irritation