Custom Services
Custom Services
Product Description
Standard and Classification
|
Standard – CE marking |
Class I Medical Device according to EU regulation 2016/425/EU |
|
Classification |
Type IIR surgical face mask according to EN-14683:19+AC2019 |
Performance
|
Laboratory test |
Tested by SITRA (ASTM F2101 EN-14683:2019 +AC:2019) |
|
Bacterial filtration efficiency |
(BEF) > 98.9% + 0.50% |
|
Microbial cleanliness |
<30 ufc/g |
|
Splash resistant |
Yes |
|
Breathability |
25 Pa/cm2 ± 2.1 PA/cm2 |
