There have been increasing reports of counterfeit or inadequate KN95 respirators entering the market from China. After updating their regulations and inspection policies in late April, Chinese authorities seized a reported assortment of 89 million masks and prevented their export.
The Canadian federal government also suspended shipments of N95 respirators from a Montreal-based supplier after about eight million of the masks made in China failed to meet specifications. This emphasizes the critical need to take extra precautions when it comes to purchasing new products.
Yesterday, the CDC shared a list identifying the Chinese manufacturers of KN95 respirators that have been tested by the National Personal Protective Technology Laboratory (NPPTL). Some passed, but many did not. Any respirator on that list that does not meet a minimum 95% filtration efficiency is defective, counterfeit, and does not meet NIOSH requirements.
As a Medical Device Establishment Licence holder, we were also informed of this notice by Health Canada who have asked that all masks failing this test be recalled and de-rated as barrier masks only. We can confirm that none of our masks or respirators are on the recall list.
At Levitt-Safety, we operate a Quality Management System that complies with ISO 9001:2015, and have been recertified yearly since our original registration in 1996. We have a robust Quality Assurance process in place, in addition to manufacturer approvals and testing results in order to qualify that the KN95 masks we have imported are good quality.
Our strong commitment to working with reputable manufacturers and our aforementioned robust quality assurance process makes us a trusted source for PPE in Canada as recognized by the Government of Ontario.
We urge everyone to inspect masks and respirators in their possession to ensure they are not on the recall list from the CDC. A reminder too that any person who is required to wear a tight fitting face piece during the course of their normal day-to-day work duties, or any person who is required to wear a tight fitting face piece for emergency response activities should be fit tested to ensure an effective seal.
A note on fit testing KN95 masks: Levitt-Safety will issue a fit test card and report for KN95 masks tested to pass the CSA protocol.
We have noticed that it may be difficult to pass a quantitative fit test with earloop style KN95 masks. We have developed an adaptor that attaches the ear loops behind the head and for many wearers this will significantly improve the fit of KN95 masks.
If you have any questions about respiratory protection products (like masks or respirators) or fit testing, we are here to help.
Thank you for continuing to put your trust in us.