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Certification | Quality | Notes | ||
KIM DUC Tested | Requirement | |||
Disposable Mask
For community usage, source control |
USA: FDA Operator number 10074394
EU: CE Declaration of Conformity ASTM 2100 – level 1 EN 14683 – Type I |
Bacterial Filtration Efficiency: 99.83% | BFE >95% | Filter material: Will be used for all Disposable Mask models |
Splash Resistance: 80mmHg & 120mmHg | 80mmHg | Outer layer material: Will be used for all Disposable Mask models | ||
Breathability:
4.6 mm H2O/cm2 |
< 5 mmH2O/cm2
Or <40 Pa/cm2 |
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Surgical mask
For medical procedures |
USA: Test by Eurofins
ASTM 2100 – level 3 Liquid barrier protection level 2 EU: Test by a Notified body lab (CENTEXBEL NB 0493) MDD 93/42/EEC Type IIR |
Tests & import capability to USA: TBA December
510(k): TBA first quarter of 2021 |
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