International Respirator | FaceMask

AWINTOO Medical Co., Ltd., produce & distribute model KN95 Protective Mask. The labeling for these respirators indicate they meet GB2626-2006 (the Chinese standard for Respiratory Protective Equipment – Non-Powered Air-Purifying Particle Respirator) and EN149:2001+A1:2009 (the European standard for Respiratory Protective Devices – Filtering Half Masks to Protect Against Particles – Requirements, Testing, Marking). 

The respirators are submitted for evaluation at test labs and been certified. The samples were tested using a modified version of NIOSH Standard Test Procedure (STP) TEB-APR-STP-0059. This modified assessment plan can be found here. 

Certificate of approval was provided with the samples received; therefore, the authenticity of the claims has been validated. The maximum and minimum filter efficiency was 35.00% and 24.10%, respectively. The respirators measured less than 95%. While the above-listed product classifications have similar performance requirements to NIOSH approved devices, NIOSH approve with their knowledge about the sustained manufacturer quality system and product quality control for these products. 

The product’s handling and exposures after leaving manufacturer control is all depending on transportation safety department. In addition, this product is an ear loop design. Currently, there are no NIOSH-approved products with ear loops; NIOSH-approved N95s have head bands. Furthermore, limited assessment of ear loop designs, indicate difficulty achieving a proper fit. While filter efficiency shows how well the filter media performs, users must ensure a proper fit is achieved. 

• Filter performance – (must be ≥ X% efficient) ≥ 95%

• Test agent : NaCl  ;  Flow rate : 85 L/min.

• Total inward leakage (TIL)* – tested on human subjects each performing exercises**  ≤ 8% leakage (arithmetic mean)

• Inhalation resistance – max pressure drop ≤ 350 Pa   ;  Flow rate : 85 L/min.

• Exhalation resistance - max pressure drop ≤ 250 Pa   ;  Flow rate : 85 L/min.

• Exhalation valve leakage requirement  :  Depressurizat ion to 0 Pa ≥ 20 sec

• Force applied  :  -1180 Pa

• CO2 clearance requirement  ≤ 1%

NIOSH approval through the official approval process. This assessment was developed as an assessment of the filter efficiency for those respirator’s represented as certified by an international certification authority, other than NIOSH, to support the availability of respiratory protection to US healthcare workers due to the respirator shortage associated with COVID-19. Only particulate filter efficiency was assessed. The results provided in this letter are specific to the subset of samples that were provided to NPPTL for evaluation.

Definitions:

Filter performance – the filter is evaluated to measure the reduction in concentrations of specific aerosols in air that passes through the filter. 

Test agent - the aerosol that is generated during the filter performance test. 

Total inward leakage (TIL) – the amount of a specific aerosol that enters the tested respirator facepiece via both filter penetration and faceseal leakage, while a wearer performs a series of exercises in a test chamber. 

Inward leakage (IL)– the amount of a specific aerosol that enters the tested respirator facepiece, while a wearer performs a normal breathing for 3 minutes in a test chamber. The test aerosol size (count median diameter) is about 0.5 micro meter. 

Pressure drop – the resistance air is subjected to as it moves through a medium, such as a respirator filter. IMPORTANT: Always read and follow respirator user instructions.