On April 3, 2020, FDA issued an update to the Non-NIOSH Approved Respirator Emergency Use Authorization (EUA) concerning non-NIOSH-approved respirators that have been approved in other countries.
Other countries approve respirators for occupational use according to country-specific standards. These products are evaluated using some methods that are similar to those used by NIOSH. Some methods are different but are expected to provide protection similar to NIOSH-approved filtering facepiece and elastomeric respirators. Devices supplied by current NIOSH-approval holders producing respirators under the standards authorized in the listed countries are expected to provide the protection indicated, given that a proper fit is achieved. Therefore, they are considered to be suitable alternatives to provide protection during the COVID-19 response when supplies are short.
Within the following tables, the country, conformity assessment standards, standards and guidance documents, acceptable product classification, and NIOSH classification are provided in alphabetical order. All of these respirators have protection factors of at least 10 in the countries listed below, as outlined in the standards and guidance documents specified.
Non-NIOSH approved products developed by manufacturers who are not NIOSH approval holders are expected to meet the performance requirements if they have been issued a certificate of approval by an authorized test laboratory indicating they conform to the standards below. Non-NIOSH-approved products developed by manufacturers who are not NIOSH approval holders, including only products approved by and received from China, should only be used in crisis situations when no other NIOSH-approved N95 respirator (or a listed device from one of the other countries identified within the FDA EAU) is available; they should not be used during aerosol generating medical procedures unless the alternative is a loose-fitting surgical mask or improvised device.
Respirators Approved Under Standards Used in Other Countries That Are Similar to NIOSH-Approved N95 Filtering Facepiece Respirators
Respirator-Cartridge Units Approved Under Standards Used in Other Countries That Are Similar to NIOSH-Approved Elastomeric Half-Facepiece Respirators