Can KN95 masks be exported to the United States?

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With the rapid spread of the new coronary pneumonia epidemic, European and American countries have become the hardest hit areas. In the process of prevention and control of the epidemic, due to the serious shortage of medical masks, protective clothing and other medical supplies, Europe and the United States have released a huge demand for protective equipment.

China KN95 mask (approved by FDA)



The US FDA once excluded the Chinese standard KN95 mask from the scope of EUA authorization. Recently, the US FDA issued a document on its official website to obtain EUA authorization for non-NIOSH certified respirators (masks) produced in China. This newly released document marks that KN95 masks produced in accordance with Chinese standards have been officially approved by the US government.



The three principles of the EUA authorization for masks produced in China:

1. The FDA can verify other types of filter mask respirator (FFR) produced by manufacturers with one or more NIOSH certified products in accordance with applicable authorization standards in other countries / regions;

2. If authorized by other regions outside of China, FDA can verify;

3. A test report issued by an independent test laboratory can show that the performance of its products meet the applicable test standards, FDA can verify.

Note to this article: If this principle is met, manufacturers of masks designed and verified in accordance with Chinese standards can obtain EUA authorization.

* The FDA used a line of footnotes in very small fonts for the most critical explanation. (Source: FDA website) Chinese manufacturers can submit different application materials based on these three principles. The list of submitted application materials is as follows:

01

In accordance with the first principle above, the following materials need to be submitted:

1. The name, model and NIOSH approval number of the NIOSH approved respirator;

2. A copy of the manufacturer’s name, address, model and product label of the respirator you want to obtain authorization;

3. The number of imported respirators in public health emergencies.

02

In accordance with the second principle above, the following materials need to be submitted:

1. A copy of the manufacturer’s name, address, model and product label of the respirator you want to obtain authorization;

2. Market sales authorization documents / certificates issued by other regulatory agencies or conformity assessment agencies (including authorization numbers and names of conformity assessment agencies);

3. Certificate of compliance with applicable standards;

4. The number of imported respirators expected in public health emergencies.

03

In accordance with the third principle above, the following materials need to be submitted:

1. A copy of the manufacturer’s name, address, model and product label of the respirator you want to obtain authorization;

2. The name of the testing institution;

3. Certificate of compliance with applicable standards;

4. The test report shows that it meets the applicable performance standards;

5. The number of imported respirators expected in public health emergencies.






🎭🎭FDA certified Chinese manufacturers

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