3 Ply Medical Grade Face Mask

3 Ply Medical Grade Face Mask

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.