Keeping You Safe.
EN 14683 Type IIR
ASTM Level 3
HSA License : ES0501141
CE Identifier : F99EA50-C8
FDA Establishment Owner : 10078028
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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
|
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
|
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
|
SURGISYL Masks come in a reusable ziplock travel pouch to prevent masks contamination.
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
|
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
|
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
|
