Features – FDA Appendix A: Authorized Respirators – Produced in an ISO Certified Medical Facility -Our KN95 respirators are equivalent or higher than the N95 NIOSH rated particulate filtration efficiency.
Specifications – Filter performance, which is the evaluation of the filler to measure the reduction in concentrations of specific aerosols in air that passes through the filter. > 95% Efficiency – Test Agent NaCi. – Flow Rate 85 L/min. – Total inward leakage (TIL) <1%. – Inhalation resistance – maximum pressure drop <150 Pa
Particulate Filter Efficiency Testing The maximum and minimum penetration value will be reported for the set of 10 respirators. Each respirator will be tested on a TSI 8130 and/or 8130A Automated Filter Tester, set to the following parameters:
a. The flow rate will be set to 85.0 ± 4.0 Liters/Minute. b. Aerosol concentration will not exceed 200 mg/m3. c. The particle size distribution will be 0.075 ± 0.020 micrometer d. Each respirator will be tested for 10 minutes. e. Maximum penetration will be recorded for each individual respirator w/ a geometric standard deviation not exceeding 1.86.
*The above-listed product classification has similar performance requirements to NIOSH-approved devices. This assessment was developed as an assessment of the filter efficiency for those respirators represented as certified by an international certification authority, due to the respirator shortage associated with COVID-19. These results will be used to update the CDC guidance for Crisis Capacity Strategies.
This assessment provides useful information about the filter efficiency of respirators that may be used by healthcare workers in national emergency situations