K N 9 5 RESPIRATOR REQUIREMENTS FROM THE FDA


 Q- IS THE N 9 5 APPROVED BY THE CDC? A- Yes, click here and refer to Shanghai Dasheng Health Products Manufacturing Company number 84A-4329 https://www.cdc.gov/niosh/npptl/topics/respirators/disp_part/n95list1sect3.html  

 

Q- ARE YOUR K N 9 5 RESPIRATORS FDA REGISTERED? A- We are FDA registered. Click here to view our products on the FDA website. WENZHOU SHENYUAN Medical Equipment CO. LTD  

 

Q- ARE YOU ON THE FDA’S UPDATED EMERGENCY USE AUTHORIZATION LIST FOR K N 9 5 RESPIRATORS? A- Due to delays with the Covid 19 national emergency, we are in the FDA approval process which may take up to 3 weeks. click here to view the approved list of K N 9 5 Distributors.  

 

Q- WHAT DOES IT MEAN TO BE ON EMERGENCY USE AUTHORIZATION LIST? A- The above-described authorized respirators listed in Appendix A, like the 3M 9001 particulate respirator, when labeled as described in this letter, are authorized to be distributed to and used in healthcare settings by HCPs when used in accordance with CDC’s recommendations under this EUA, despite the fact that they do not meet certain requirements otherwise required by applicable federal law. Click here and see Appendix A.  Please see page 5 for further details.   

 

Q- WERE YOU ON THE OLD LIST OF APPROVED K N 9 5 SUPPLIERS AND TAKEN OFF?  A- No, we were never on the old list. Click here to view the old list of approved respirators.   Q- HOW CAN I BE SURE THESE K N 9 5 RESPIRATORS ARE SAFE TO USE?  A- See the test results HERE.  

 

Q- WHY ARE YOUR PACKAGES MARKED NON-MEDICAL DEVICE?  AClick here to see the enforcement policy for N 9 5 Respirator Guidance. See page 5. (Face Shields, and N 9 5 Respirators Not Intended for Medical Purpose.)  

 

Q – IS THERE DIFFERENCE BETWEEN A K N 9 5 AND N 9 5 RESPIRATORS? A-Based on this comparison from 3M, it is reasonable to consider China K N 9 5, AS/NZ P2, Korea 1st Class, and Japan DS FFRs as “equivalent” to US NIOSH N 9 5 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: https://multimedia.3m.com/mws/media/1791500O/comparison-ffp2-kn95-n95-filtering-facepiece-respirator-classes-tb.pdf  

 

Q – CAN RESPIRATORS APPROVED UNDER STANDARDS USED IN OTHER COUNTRIES, SUCH AS K N 9 5, 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 N 9 5 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 K N 9 5 respirators in this EUA because of concerns about fraudulent products listed as K N 9 5. On April 3, 2020, in response to continued respirator shortages, the FDA issued a new EUA for non-NIOSH-approved N 9 5 respirators made in China, which makes K N 9 5 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 K N 9 5 respirators as well. It explains that for the duration of the pandemic, when FDA-cleared or NIOSH-approved N 9 5 respirators are not available, the FDA generally would not object to the importation and use of respirators without an EUA, including K N 9 5 respirators. Although not required, if a K N 9 5 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. https://www.fda.gov/medical-devices/personal-protective-equipment-infection-control/faqs-shortages-surgical-masks-and-gowns International Respirator Assessment Request – K N 9 5 On February 29, 2020, CDC published guidance Strategies for Optimizing the Supply of N 9 5 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 N 9 5 respirators.”