MEKO KN-95 PROTECTIVE MASK, 5 LAYER, PFE>95%, FOLDABLE EARLOOP MASKS, 20 PER BOX

 PLEASE READ ENTIRE DOCUMENT BEFORE PURCHASE

Meko biotech is an FDA registered manufacturer of KN-95 Masks, as well as other PPE items. PLEASE NOTE - They are not currently listed on the FDA Appendix A approved list of products. 

 

With exhaustive information being published each day by the  FDA, CDC and ADA it makes it difficult to make an informed decision about what products are safe to purchase, and be effective against spread of Covid19. 

 

From our research into the the FDA guidlines, their list of approved use products is based upon hospital "OR" (operating room) and ICU (intensive care unit) use, or what they are calling "first line medical" The EUA ( Emergency Use Authorization)  has approved KN-95 masks, as long as they are proper fit, and tested to be effective as an alternative to KN-95's that are on the list or approved NIOSH N-95's. 

 

KN-95's have been approved for use by the FDA and CDC in front line applications, meaning any other use than "OR" or "ICU" use. Although we feel that dentists should perhaps fall into a higher category than OR use, due to proximity to the patient, and presence of aerosolized mists, dentists, as well as many other medical users fall into this category.  So all KN-95 masks that are being imported into the US that are not on this "OR " approved list are mandated to be marked as non-medical. Though by the Gov't mandate KN-95's are now approved to be used for medical purposes as long as they are proved effective, with the exception of  “not for OR use "  when no N-95's or approved KN-95's are readily available. 

 

Other health agencies, specifically Health Canada, has produced a list of manufacturers that they have tested and have " dis-approved" for reasons of fraudulence in product markings ( NIOSH approved when actually not ) , and faulty BFE filtration ratings. 

 

The KN-95’s that Sabra is making available are not on the Health Canada " dis-approved" list as fraudulent, or not filtering to stated standards.

 

Meko Biotech is a FDA registered manufacturer of KN-95 masks and has test report data showing their masks acheive proper levels of filtration ( see test report and FDA registration below ) 

 

Sabra Dental is not making claims that use of this product will prevent transmission of any disease, including Covid19. There are many circumstances involved such as improper fit and improper use that can effect these outcomes. Please make sure this and any mask worn has a positive facial lock ( PFL ) to help ensure good fit, as well as sanitary habits of limmited face touching, hand washing, etc to help secure yourself and your patients. 

 

 PLEASE READ THE ABOVE CAREFULLY, as we are not accepting returns on any KN-95 masks purchased. ALL SALES FINAL.