NPPTL COVID-19 Response: International Respirator Assessment

Manufacturer: Zhangjiagang Zhiyi Medical Health Products Co., Ltd.

Model Tested: Self-Priming Filter Respirator KN95

Date Tested: April 10, 2020

These findings pertain to the Zhangjiagang Zhiyi Medical Health Products Co., Ltd., KN95 Self-Priming 

Filter Respirator. The labeling for these respirators indicate they meet GB19083-2010. This is the 

Chinese standard for Technical Requirements for Protective Face Mask for Medical Use.

No certificate of approval was provided with the samples received; therefore, the authenticity of the 

claims cannot be validated.

Ten respirators were submitted for evaluation. 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.

The maximum and minimum filter efficiency of the products evaluated was 99.26% and 97.93%, 

respectively. All ten respirators measured more than 95%.

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. Therefore, even though the filter efficiency measured 

was more than 95%, users need to ensure a proper fit is achieved.

While the above-listed product classification has similar performance requirements to NIOSH-approved 

devices, NIOSH does not have knowledge about the sustained manufacturer quality system and 

product quality control for these products. NIOSH also does not have knowledge about the product’s 

handling and exposures after leaving its manufacturer’s control.

This assessment is not a part of the NIOSH respirator approval process and will in no way lead to or 

preclude 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.

These results will be used to update the CDC guidance for Crisis Capacity Strategies (during known 

shortages).
NPPTL COVID-19 Response: International Respirator Assessment

Evaluation of International Respirators

Test: Modified TEB-APR-STP-0059

Date Tested: April 10, 2020

Report Prepared: April 15, 2020

Manufacturer: Zhangjiagang Zhiyi Medical Health Products Co., Ltd.

Item Tested: Self-Priming Filter Respirator KN95

Country of Certification: China (GB19083-2010)

Filter Flow Rate

(Lpm)

Initial Filter 

Resistance 

(mmH2O)

Initial Percent 

Leakage

(%)

Maximum 

Percent Leakage

(%)

Filter Efficiency

1 85 9.5 0.736 0.736 99.26

2 85 8.2 2.07 2.07 97.93

3 85 9.3 0.831 0.831 99.17

4 85 10.0 1.46 1.46 98.54

5 85 10.2 1.31 1.31 98.69

6 85 9.3 0.849 0.849 99.15

7 85 9.4 0.943 0.943 99.06

8 85 8.9 0.765 0.765 99.23

9 85 8.6 1.09 1.09 98.91

10 85 9.8 1.24 1.24 98.76

Minimum Filter Efficiency: 97.93 Maximum Filter Efficiency: 99.26

• The test method utilized in this assessment is not the NIOSH standard test procedure that is used for certification of 

respirators. Respirators assessed to this modified test plan do not meet the requirements of STP-0059, and therefore 

cannot be considered equivalent to N95 respirators that were tested to STP-0059.

• Respirators tested may not be representative of all respirators with the same certification mark. NIOSH has no control 

over suppliers and distributors of respirators certified by other national or international parties.

• This assessment is not a confirmation that it conforms with any or all of its specifications in accordance with its 

certification mark. 

• This assessment was not a part of the NIOSH approval program. These results do not imply nor preclude a future 

approval through the NIOSH respirator approval program.

Pictures have been added to the 

end of this report.
NPPTL COVID-19 Response: International Respirator Assessment
NPPTL COVID-19 Response: International Respirator Assessment
NPPTL COVID-19 Response: International Respirator Assessment
NPPTL COVID-19 Response: International Respirator Assessment
NPPTL COVID-19 Response: International Respirator Assessment