A surgical face mask is a medical device covering the mouth, nose and chin ensuring a barrier that limits the transmission of an infective agent between the staff, surgeon and the patient.
Our surgical masks have 3 different layers:
1. Polypropylene - inner layer
2. Meltblown - middle layer (pp filter which creates the barrier)
3. Polypropylene - outer layer
In Europe, surgical face masks have to be labelled with a CE mark and meet the construction, design and performance requirements as described in EN14683 (2019) - Surgical face masks | requirements and test methods.
The performance levels of the mask have to be assessed on the finished product and in relation to their final use.
EN14683 defines 4 tests to classify the masks into different types (I, IR, II, IIR):
- Bacterial Filtration Efficiency (%)
- Breathability (Delta P) Pa/ cm2
- Resistance to penetration by synthetic blood
Splash test - mm Hg
- Microbial cleanliness