Class 1 Medical device: Disposable 3 ply Medical face mask with ear loop.
This is for use in the medical industry and has been manufactured under the guidance outlined in the medical devices directive 93/42/EEC (MDD)
This is not PPE and is not certified under the PPE Regulation (EU) 2016/42.
The item is a Type I mask which means it is suitable to reduce the risk of spread of infections.
In terms of performance the type I mask meets the below:
bacteria filtering effectiveness > 95%.
differential pressure < 40
splash resistance (not tested) Not applicable to type I
Microbial cleanliness < 30
The product is manufactured :
- following the requirements outlined in EN14683 - our manufacturer has provided evidence to show the product meets EN14683
- under an approved quality management system which meets ISO 13485, this has been performed and issued by SGS.
The product is single use only & is non sterile.
