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Home > Frequently Asked Questions > Masks & Respirators > NIOSH N95 Respirators > Are NIOSH N95 respirators approved for use in a healthcare setting?
Are NIOSH N95 respirators approved for use in a healthcare setting?
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Yes. NIOSH N95 Respirators on the NIOSH Certified Equipment List are authorized for use in healthcare settings by healthcare providers as recommended by CDC to prevent wearer exposure to pathogenic biological airborne particulates during respirator shortages resulting from the COVID-19 outbreak, pursuant to the FDA's Emergency Use Authorization (EUA) from March 2nd, 2020 and updated March 28, 2020.  They are considered a medical device for the duration of the EUA.  FLTR N95 Respirators cannot eliminate the risk of contracting COVID-19.


Users can find the respirators by searching under the manufacturer's name at the following CDC link:


Manufacturer FLTR Model No Model No Approval No
FLTR, Inc. HLT157 SS9001-N95 TC-84A-8084
Shining Star Electronic Technology Co., Ltd. HLT157 SS9001-N95 TC-84A-8084
Suzhou Fangtian Industries Co., Ltd. HLT158 FT-N010 TC-84A-7701


Shining Star

Suzhou Fangtian

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