CDC announces acceptance of Chinese standard masks such as KN95 - Industry news

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CDC announces acceptance of Chinese standard masks such as KN95

Our Admin
2020-03-26
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On March 17, the United States Centers for Disease Control and Prevention (CDC) released "Strategies for Optimizing the Supply of N95 Respirators: Crisis / Alternate Strategies", pointing out that during the COVID-19 epidemic, when the supply of N95 masks was insufficient, masks produced according to the standards in the table below are suitable replacements for N95 masks. These include masks produced using Chinese standards GB 2626-2006 and GB / T 18664-2002.

Note: At present, during the epidemic period, entering the US market requires importers to apply to the FDA for emergency mask qualification. N95 masks that meet the following standards can simplify the original US FDA registration process and the NIOSH testing process and put them into use quickly.

 

Use of respirators approved under standards used in other countries that are similar to NIOSH-approved N95 respirators

Use of respirators approved under standards used in other countries that are similar to NIOSH-approved N95 respirators

Country

Performance Standard

Acceptable product classifications

Standards/Guidance Documents

Protection Factor ≥ 10

Country

Performance Standard

Acceptable product classifications

Standards/Guidance Documents

Protection Factor ≥ 10

Australia

AS/NZS 1716:2012

P3

P2

AS/NZS 1715:2009

YES

Australia

AS/NZS 1716:2012

P3

P2

AS/NZS 1715:2009

YES

Brazil

ABNT/NBR 13698:2011

PFF3

PFF2

Fundacentro CDU 614.894

YES

Brazil

ABNT/NBR 13698:2011

PFF3

PFF2

Fundacentro CDU 614.894

YES

China

GB 2626-2006

KN 100 KP100

KN95 KP95

GB/T 18664—2002

YES

China

GB 2626-2006

KN 100 KP100

KN95 KP95

GB/T 18664—2002

YES

Europe

EN 149-2001

FFP3

FFP2

EN 529:2005

YES

E

urope

EN 149-2001

FFP3

FFP2

EN 529:2005

YES

Original CDC announcement address: https://www.cdc.gov/coronavirus/2019-ncov/hcp/respirators-strategy/crisis-alternate-strategies.html


Recently, Europe and the United States urgently relaxed access requirements for epidemic prevention materials such as masks (CE certification and FDA certification). Products that require agency certification can be exported before completing the compliance assessment process (that is, before obtaining the CE / FDA mark), but to ensure certification Work will continue to complete. (Details) Europe and the United States Urgently Relax Admission Requirements for Epidemic Materials

The competent authorities of EU member states can evaluate and centrally purchase quarantine products without CE marking during the epidemic period. The products can only be provided to medical personnel and cannot be sold on the market. If your product is not purchased centrally by the government and is to be sold on the local market, it does not fall into the scope of the above relaxed access conditions.

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