Health Canada continues to assess all sources of information related to respirators that may not meet safety and effectiveness standards, and takes action to ensure that products that do not meet the applicable standards are relabelled as face masks for use in settings where 95% filtration is not required. In addition to the testing conducted by the National Institute for Occupational Safety and Health (NIOSH), Health Canada has assessed results from other laboratories and will continue to update the list of devices that must be relabelled as face masks in order to be distributed in Canada. 

Issue
Health Canada is committed to ensuring that the medical devices available to Canadians meet the necessary safety and effectiveness standards. The Department has contacted companies that may be importing or distributing certain respirators, including KN95 respirators, that may not meet expected performance standards in Canada to request that they stop sale and relabel the products as face masks instead of respirators.

This follows the recent U.S. Food and Drug Administration (FDA) communication regarding concerns that certain filtering facepiece respirators from China may not provide consistent and adequate respiratory protection based on testing conducted by the National Institute for Occupational Safety and Health (NIOSH) – National Personal Protective Technology Laboratory (NPPTL) of the Centers for Disease Control and Prevention (CDC).  

Health Canada has asked importers and distributors that may have imported respirators that do not meet performance standards to notify their customers and relabel products to indicate that while these masks may not meet the standards required for frontline healthcare workers, they could be used as face masks in settings where a 95% filtration is not needed. The products are not being removed from the market.

This action does not implicate KN95 respirators purchased by the Government of Canada and tested by the Public Health Agency of Canada (PHAC). Before allocating any personal protective equipment to the provinces or territories for frontline healthcare workers, PHAC conducts a quality verification. For KN95 respirators, this includes a visual inspection to check for defects in design and construction, and testing to confirm that they meet filtering specifications. KN95 respirators distributed to provinces and territories by PHAC meet the Government of Canada’s technical specifications for healthcare settings for COVID-19 response.

Affected products
Health Canada is following up with companies that may have imported and distributed respirators that were tested by the CDC NPPTL and did not meet performance standards.

What you should do

• Provincial and territorial health authorities and healthcare institutions should review their inventories of respirators to confirm that they meet the Government of Canada technical specifications for healthcare settings for COVID-19 response.
• Canadians using these masks outside healthcare settings can continue to do so.
• Report any health product adverse events to Health Canada.

What Health Canada is doing
Health Canada will ensure that any companies that have distributed impacted products take appropriate action to stop selling any impacted products, notify customers and relabel existing stock as face masks instead of respirators. Should additional safety concerns be identified, Health Canada will take appropriate action and inform Canadians, as necessary.

Related links
Fraudulent and unauthorized N95 respirators may not protect consumers against COVID-19 
Canada.ca/coronavirus 
International Assessment Results – Not NIOSH-approved

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