2022/01/26

HEAVYWEIGHT: VENETIAN MASKS ARE THE FIRST MANUFACTURERS IN CHINA TO BE APPROVED BY THE FDA

On April 3, 2020, the US FDA released the EUA authorization document on its official website.

Non-NIOSH certified respirators (masks) manufactured in China.

 

 

 

The US FDA once excluded Chinese standard KN95 masks from the scope of EUA authorization. This newly released document marks that KN95 masks produced in accordance with Chinese standards have been officially recognized by the US official.

 

Three principles for EUA authorization of masks produced in China:

1. Other models of filtering facepiece respirators (FFRs) produced by manufacturers with one or more NIOSH certified products in accordance with applicable authorization standards in other countries/regions can be verified by the FDA;
2. FDA can verify the authorization from other regions outside China;
3. If there is a test report issued by an independent testing laboratory, which can show that its product performance meets the applicable test standards, the FDA can verify it.

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Chinese manufacturers can submit different application materials according to these three principles. The list of submitted application materials is as follows:

1. Those who meet the first principle above need to submit the following materials:

- the manufacturer's name, model number and NIOSH approval number of the NIOSH-approved respirator;

- a copy of the manufacturer's name, address, model number and product label of the respirator for which authorization is to be obtained;

- Estimated number of respirators to be imported during a public health emergency.

 

2. Those who meet the second principle above need to submit the following materials:

- a copy of the manufacturer's name, address, model number and product label of the respirator for which authorization is to be obtained;

- marketing authorization documents/certificates issued by other regulatory bodies or conformity assessment bodies (including the authorization number and the name of the conformity assessment body);

— a certificate of compliance with the applicable standard;

- Estimated number of respirators to be imported during a public health emergency.

 

3. Those who meet the third principle above need to submit the following materials:

- a copy of the manufacturer's name, address, model number and product label of the respirator for which authorization is to be obtained;

- the name of the testing body;

— a certificate of compliance with the applicable standard;

- a test report showing compliance with the applicable performance standards;

- Estimated number of respirators to be imported during a public health emergency.

 

ON APRIL 3, 2020, THERE ARE 2 MANUFACTURERS OF NON-NIOSH-CERTIFIED RESPIRATORS PRODUCED IN CHINA THAT HAVE BEEN APPROVED BY THE FDA.

THE SPECIFIC MODELS ARE AS FOLLOWS:

 

 

1. KN95 anti-particulate respirator (mask) of BYD brand model DG3101 of BYD Precision Manufacturing Co., Ltd.;

2. The respirator (mask) of Weini Technology Development Co., Ltd. is FFP2 NR E-300, FFP2 NR E-680, FFP2 NR 952, FFP2 NR F-820.

 

FDA document link: https://www.fda.gov/media/136664/download
Authorized company link: https://www.fda.gov/media/136663/download (The list of FDA-authorized companies will be continuously updated)