Table of Contents
- FAQs About KN95 Face Mask Requirements from the FDA
- Does the CDC Approve the N95 Masks?
- Is Every Dealer On the FDA’S Updated Emergency Use Authorization List for KN95 Face Masks?
- What Does It Mean to Be On Emergency Use Authorization List?
- Were most Dealers On the Old List of Approved KN95 Masks and Taken Off?
- How Can I Be Sure These KN95 Masks Are Safe to Use?
- Why Are Your Packages Marked as a Non-Medical Device?
- Is There Difference Between a KN95 and an N95 Face Mask?
- Resources and References:
FAQs About KN95 Face Mask Requirements from the FDA
Here are some of the most frequently asked questions about the KN95 masks.
Does the CDC Approve the N95 Masks?
Yes, KN95 PPE masks are certified face masks for sale. You can check the CDC approval here.
Is Every Dealer On the FDA’S Updated Emergency Use Authorization List for KN95 Face Masks?
No, most dealers are yet to apply. However, some reports that they are in the process of applying, which may take up to 3 weeks. Here is a list of the approved list of KN95 Mask Sellers that you should check out before getting a KN95 masks medical supply.
What Does It Mean to Be On Emergency Use Authorization List?
The authorized respirators listed in Appendix A linked below, like the 3M 9001 particulate respirator mask, when labeled as described in this letter, are authorized to be distributed to and used in healthcare settings by HCPs. They must be used in accordance with CDC’s mask recommendations under this EUA, despite the fact that they do not meet specific requirements otherwise required by applicable federal law.
Were most Dealers On the Old List of Approved KN95 Masks and Taken Off?
No, most dealers were never on the old list. You can check with the FDA for approved masks and check your specific dealer.
How Can I Be Sure These KN95 Masks Are Safe to Use?
There are various safety tests that you can conduct. See the test results HERE.
Why Are Your Packages Marked as a Non-Medical Device?
You can click here to see the enforcement policy for N95 Face Mask Guidance.
Is There Difference Between a KN95 and an N95 Face Mask?
According to a comparison from 3M, it is reasonable to consider China’s kn95 coronavirus masks, AS/NZ P2, Korea 1st Class, and Japan DS FFRs as “equivalent” to US NIOSH N95 and European FFP2 respirators. They are similar for filtering non-oil-based particles such as those resulting from wildfires, PM 2.5 air pollution, volcanic eruptions, or bioaerosols (e.g., viruses). Nonetheless, before choosing a respirator, users should consult their local respiratory protection regulations and requirements or check with their local public health authorities for selection guidance as well as the KN95 mask price to match your budget.
If you have more questions about the KN95 mask, reach out to us for more information. Alternatively, you can consult a dealer near you to get all the information.