With comfort in mind, our form-fitting masks are designed with comfortable ear loops and a soft white inner layer. It is also breathable and hypoallergenic.
SURGISYL Masks are registered with the U.S. Food and Drug Administration (FDA) under the operator number 10078028.
FDA Device Classification Name: FACE MASK FOR GENERAL PUBLIC/HEALTHCARE PERSONNEL PER IIE GUIDANCE.
| HSA License | ES0501141 |
| FDA Establishment Owner | 10078028 |
| CE Identifier | F99EA50-C8 |
| EN 14683:2019 | Type IIR |
| BFE (%) |
≥99
|
| PFE (%) |
≥99
|
| ASTM F2100-19 Level | Level 3
|
| Breathability (Delta P) |
<60Pa/cm2.
|
| Microbial Cleanliness |
<30cfu/g.
|
|
Synthetic Blood Penetration Test
|
≥16.0 kPa.
|
| Flammability Test | Class 1
|
