CE or FDA Certified Products
We would like to explain the different variants of face masks which are available to help you further.
3 Ply Face Mask – In accordance to EN 14683:2019+AC:2019
Surgical face masks are intended to limit the transmission of infective agents. Surgical face masks can also incorporate a microbial barrier that is designed to be effective in reducing the emission of infective agents from the nose and mouth of a carrier or a patient with clinical symptoms. Surgical masks are intended to be a barrier to infection of others though they do offer limited protection to the wearer.
Surgical face masks are classified into two main types;
Type I – these masks should only be used by patients and other persons to reduce the risk of spread of infections particularly in epidemic or pandemic situations. Type I masks are not intended for use by healthcare professionals in an operating room or in other medical settings with similar requirements. These masks can also be certified with a test report for a bacterial filtration efficiency of 98%.
Type II and Type IIR – these masks are normally intended for use by healthcare professionals in an operating room or other medical settings with similar requirements. Type II is further divided according to whether or not the mask is splash resistant. The R signifies splash resistance. These masks can also be certified with a test reoprt for a bacterial filtration efficiency of 99%.
These products are certified under the European Medical Devices Regulation as a Class I device, so they must be CE marked based on the manufacturer’s self-declaration unless they are supplied as sterile.
Protective Mask – In Accordance to EN 149:2001+A1:2009
Protective masks are designed to protect against particulates such as dust particles and various viruses in the air. These masks, unlike surgical masks, protect the wearer from inhaling infectious agents or pollutants in the form of aerosols, droplets, or small solid particles. The wearer must be free of facial hair for this type of mask to be effective and should be ‘fit tested’ to ensure that the wearer has the appropriate, specific mask. These masks can be used in domestic, industrial and healthcare applications.
The EN 149 standard defines three classes of filter efficiency for these masks;
The NHS is stipulating FFP3 in high risk areas and FFP2 in lower risk areas. In addition, masks are classified as single shift use only (marked NR on the product) or as re-usable i.e. more than one shift (marked R on the mask).