Q: WHY ARE YOUR PACKAGES MARKED NON-MEDICAL DEVICE?
A: Click here to see the enforcement policy for N95 Face Mask Guidance. See page 5. ( B. Face Masks, Face Shields, and N95 Respirators Not Intended for Medical Purpose.)
Q: IS THERE DIFFERENCE BETWEEN A KN95 AND A N95 FACE MASK?
A: Based on this comparison from 3M, it is reasonable to consider China KN95, AS/NZ P2, Korea 1st Class, and Japan DS FFRs as “equivalent” to US NIOSH N95 and European FFP2 respirators, for filtering non-oil-based particles such as those resulting from wildfires, PM 2.5 air pollution, volcanic eruptions, or bioaerosols (e.g. viruses). However, prior to selecting a respirator, users should consult their local respiratory protection regulations and requirements or check with their local public health authorities for selection guidance. Here is an article from the FDA:
Q: CAN RESPIRATORS APPROVED UNDER STANDARDS USED IN OTHER COUNTRIES, SUCH AS KN95, BE USED?
A: Yes. The FDA is working diligently to mitigate any potential shortages in the supply chain and taking action to assure health care personnel on the front lines have sufficient supplies of respiratory protective devices. The FDA concluded, based on the totality of scientific evidence available, that certain imported respirators that are not NIOSH-approved are appropriate to protect the public health or safety.
On March 24, 2020, the FDA issued an Emergency Use Authorization (EUA) for importing non-NIOSH-approved N95 respirators. Under this EUA, among other criteria, the FDA accepts marketing authorization from Australia, Brazil, Europe, Japan, Korea, and Mexico who have similar standards to NIOSH. The FDA did not list KN95 respirators in this EUA because of concerns about fraudulent products listed as KN95. On April 3, 2020, in response to continued respirator shortages, the FDA issued a new EUA for non-NIOSH-approved N95 respirators made in China, which makes KN95 respirators eligible for authorization if certain criteria are met, including evidence demonstrating that the respirator meets certain standards.
The FDA also issued guidance outlining a policy to help expand the availability of general use face masks for the general public and respirators for health care professionals during this pandemic. The guidance applies to KN95 respirators as well. It explains that for the duration of the pandemic, when FDA-cleared or NIOSH-approved N95 respirators are not available, the FDA generally would not object to the importation and use of respirators without an EUA, including KN95 respirators. Although not required, if a KN95 respirator does not have an EUA, the FDA encourages importers to take the appropriate steps to verify the product’s authenticity prior to importing.
The FDA has adjusted its import screening to further expedite imports of legitimate products and is continually monitoring its import systems to prevent and mitigate any potential issues. The FDA is ready and available to engage with importers to minimize disruptions during the importing process.
International Respirator Assessment Request – KN95
On February 29, 2020, CDC published guidance Strategies for Optimizing the Supply of N95 Respirators. This guidance provides Crisis Alternate Strategies that includes the option: “Use of respirators approved under standards used in other countries that are similar to NIOSH-approved N95 respirators.”