N95 SURGICAL RESPIRATOR MASK

Description of Event or Problem

I WAS LOOKING FOR THE BEST MASKS I COULD FIND AT THE DRUGSTORE IN (B)(6). PARTICULARLY, ONE THAT WAS RATED IN SOME WAY. I GOT A BOX OF 2 N95 RESPIRATORS THAT WERE LABELED AS "SURGICAL MASKS". FURTHER INVESTIGATION SHOWED THAT THEY AREN'T ACTUALLY REGISTERED AS A MEDICAL DEVICE, AND INSTEAD, THEY ARE ONLY REGISTERED WITH NIOSH. FURTHER, THERE WAS SOME VERY CONFUSING THINGS GOING ON WITH THE NAME OF MANUFACTURERS AND THE REF NUMBER ON THE PRODUCTS. THE MASKS THEMSELVES HAD A (B)(4) NUMBER ON IT AS DID THE COC. THE COC MENTIONS THEY WERE MANUFACTURED BY MAKRITE FOR (B)(4) WHILE THE OUTER BOX CLAIMS THEY WERE MANUFACTURED BY MAKE RITE FOR (B)(4). SOME RESEARCH SHOWS THAT THE (B)(4) ONES MIGHT BE REGISTERED AS A MEDICAL DEVICE, BUT I COULDN'T LOCATE WHERE (B)(4) WAS REGISTER AS A DISTRIBUTOR FOR THIS CLASS OF PRODUCT.