| Property | Units | USA | EU | Test Standard |
| Bacteria Filtration Efficiency BFE |
% | ≥ 95 | ≥ 95 | ASTM F2101 / EN14683 Annex B |
| Sub-micron Particulate Filtration Efficiency at 0.1um |
% | – | ≥ 95 | ASTM F2299 |
| Resistance to Penetration By Synthetic Blood |
mmH2O @ kPa |
– | ≥ 80 | ASTM F1862 / EN 14683 ISO 22609 |
| Microbial Cleanliness | Cfu/g | ≤ 30 | – | EN14683 Annex D ISO11737-1 |
| Differential Pressure | Pa/cm2 @ mmH2O/cm? |
≤ 40 | ≤ 5 | ASTM F2101 EN 14684 Annex C |
| Flame Spread | NA | – | Class 1 | 16 CFR 1610 |
Bacterial filtration efficiency ASTM F2101-19
| Test Side | : Side without strips (Inside) |
| Pre-Conditioning | : Minimum of 4 hours at 21±5oC and 85±5% R.H. |
| Dimensions of test specimen | : 174 mm x 95 mm |
| BFE Test Area | : 49 cm2 |
| BFE Flow Rate | : 28.3 l/min |
| Test bacteria | : Staphylococcus aureus ATCC 6538 |
| Mean Particle Size | : 2.9 ?m |
| Positive Control Average | : 2.2 x 103 CFU |
| Negative Monitor Count | : < 1 CFU |
Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres (ASTM F2299/F2299M-03 (Reapproved 2017))
| Test Side | : Side with strips (Outside) |
| Pre-Conditioning | : Minimum of 4 hours at 21±3oC and 30-50±5% R.H. |
| Test Condition | : 21±3oC and 50±5% R.H. |
| Test Area | : 41.61 cm2 |
| Face Velocity | : 18.7 cm/s |
| Particle Size | : 0.1 ?m |
| Average Filtration Efficiency | : 99.70% |
| Standard Deviation | : 0.266 |
| Test Specimen | Pressure Drop(in H2O) | Test Article Counts | Average Control Counts | Filtration Efficiency (%) |
| 1 | 0.489 | 49 | 77112 | 99.94 |
| 2 | 0.489 | 134 | 78565 | 99.83 |
| 3 | 0.489 | 179 | 82965 | 99.78 |
| 4 | 0.489 | 236 | 84587 | 99.72 |
| 5 | 0.489 | 681 | 90632 | 99.25 |
Note: The procedure incorporated a non-neutralized challenge. The non-neutralized aerosol is also specified in the FDA guidance document on surgical face masks.
