50 MASKS PER BOX
COLOR: BLACK
Level 3 Earloop Surgical Procedure Mask features slip-on convenience, provides fluid resistance and => 99% Bacterial Filtration Efficiency (BFE).
Specification & Certification:
- ASTM Minimal Standard: High Barrier
- High fluid resistance: 160mmHg (Type IIR)
- PFE: > 99%
- BFE: > 99% (Type IIR)
- Breathability - Delta P: < 5.0 H2O/cm² (Type IIR)
- Flame Spread: Class I
- Certification: CE, FDA, ISO13485, EN14683
- Fluid resistant outer layer: ASTM F2100
- Fluid resistant inner layer: NELSON
- Non Sterile
ASTM performance metrics and levels
| Test |
ASTM Level 1 |
ASTM Level 2 |
ASTM Level 3 |
|
Fluid Resistance |
80 mmHg |
120 mmHg |
160 mmHg |
| Filtration – BFE |
> 95% |
> 98% |
> 98% |
| Filtration - PFE |
> 95% @ 0.1 µg |
> 98% @ 0.1 µg |
> 98% @ 0.1 µg |
| Delta P - Breathability |
< 4.0 mm H2O/cm3 |
< 5.0 mm H2O/cm3 |
< 5.0 mm H2O/cm3 |
|
Flame Spread |
Class 1 | Class 1 |
Class 1 |
A procedural mask is designed for use when performing patient procedures or when a patient is in isolation to protect the patient from contaminants. Procedure masks protect both the patient and health-care provider from transferring respiratory secretions, bodily fluids, or other potentially infectious material. Procedure masks have ear loops rather than ties.
Warnings
This device is not designed, sold, or intended for use except as indicated.
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