To KN95 or Not? That is the Question

Posted by Jubi Kang on June 3, 2020

To KN95 or Not? That is the Question

Lately in the news there has been much discussion and confusion surrounding the KN95 masks. Hopefully we can clear up any confusions with the information below.

There have been media reports posted about KN95 masks that was based on both this bulletin from Health Canada and based on some unsubstantiated volunteer based testing completed by the CDC:

https://www.cdc.gov/niosh/npptl/respirators/testing/NonNIOSHresults.html

Health Canada Bulletin:

https://assets.documentcloud.org/documents/6889848/Recall-of-KN95-Respirators.pdf

According to the bulletin, Health Canada issued a recall on KN95 RESPIRATORS and not MASKS. There is a difference. The products we sell on our websites were never listed as respirators as we do not sell respirators. We sell masks.

What is this all about?

There is a lot of controversy and misunderstandings about KN95 masks and there are a lot of ambiguous facts in the media reports. There are no masks that are 'blacklisted' or 'banned' by Health Canada and the same goes for the CDC and the FDA.

Conversely, there are no 'approved' masks either. The FDA provides certificates of registrations but not 'approvals' for masks. You can search for registered suppliers here: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm

In case this is not confusing enough, the FDA does have 'approvals' on respirators where as of today's date, there are only 14 manufactures that are approved by the FDA for respirators. This is often referred to as the 'Appendix A'

.

See: https://www.fda.gov/media/136663/download

The Raw Office only sells FDA and CE approved masks

The masks that we sell are FDA Registered and CE Approved and always have been. We only sell FDA registered and CE masks.

The Raw Office also puts all of the masks we sell through independent testing before being shipped to Canada. Any manufacturers that don’t comply with our high standards are immediately removed from our websites. Here is an image of one of manufacturer's KN95 masks achieving a BFE % filtration rate of 100% and a PFE% of 99.41% at an independent lab overseas.

The minimum rate for KN95 is 95%. The results achieved are far better and comply with medical standards even though we are not advertising these KN95 as medical grade:

We make sure every product gets through independent tests for North America

We have also taken additional steps to temporarily pause one of the many brands of KN95 masks we sell until we get back the independent test results. The masks we have paused for the time being is branded as “Yohan”.

The Yohan masks did pass inspection prior to being shipped to Canada but the unsubstantiated CDC website is showing otherwise. So we are being cautious and pausing Yohan until our North America side tests are complete.

The CDC website states that they make “no representation as to the authenticity of the samples received and assessed.” And further states “These results are not to be used by manufacturers, distributors, suppliers, and importers to make claims about their products and/or to influence purchasers.“

As such there is much confusion on this KN95 issue and the authenticity and dependability of their website is questionable. See this statement on the CDC website:

“NIOSH has been informed that many legitimate manufacturers in China have been counterfeited. In such cases, NIOSH has no way of verifying which products are counterfeit and which are authentic. While the manufacturer listed in the table is shown as the manufacturer of the product evaluated, NIOSH has been informed that some of these are actually counterfeit products. Some products with legitimate manufacturer names, showing poor filter penetration results (<95%), are counterfeit products. A number of manufacturers have also informed NIOSH that they did not produce the products associated with their name. NIOSH urges purchasers of masks and respirators that may have questions about the authenticity of these products to contact directly the manufacturers and others in the supply chain as needed to verify that they are obtaining legitimate products. Manufacturers denoted with an asterisk(*) have informed NIOSH that the product evaluated was not manufactured by them, and should be considered as counterfeit and a misuse of their company name.”

We offer options!

Therefore, we want you to be happy and confident in your KN95 purchase, so if you are not comfortable with the product you currently have from us, we are offering you a few options:

1. Exchange your current KN95 Masks for other KN95 brands that we have in stock at no extra charge with free pick up and free delivery.

2. Return your KN95 masks and receive a full refund for your KN95 Masks (free pickup).

3. Keep your current face masks if you are comfortable, as they have passed all necessary requirements and we ourselves are using these masks everyday.

If you would like to exchange or receive a refund for the masks you have purchased, please email support@therawoffice.com and we will help you get this completed smoothly. Please provide us with your full name and order number when you send us an email.

Please know that we are committed to ensuring we offer all clients the highest quality of supplies and are working constantly to meet all of your needs!

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