N95 PARTICULATE RESPIRATOR

Description of Event or Problem

LIED ABOUT FDA APPROVAL; ON (B)(6) 2020 I PURCHASED 3 PACKS (2 IN EACH PACK) OF N95 PARTICULATE RESPIRATOR MASKS FROM (B)(6) AT THIS WEBSITE: (B)(6). MY ORDER NUMBER IS (B)(6). THEIR SITE SAID THE MASK WAS FDA REGISTERED AND A (B)(6) SEARCH SAID: "(B)(6). N95 RESPIRATOR MASK REUSABLE, (FDA APPROVED) AND FULL-FACE SAFETY ANTI-SPLASH PROTECTIVE SHIELD ARE NOW AVAILABLE AT OUR ONLINE STORE. INVENTORY IS CURRENTLY VERY LIMITED. PRIORITIZED FOR OLDER ADULTS AND HEALTH WORKERS ON THE FRONTLINES RESPONDING TO COVID-19." I RECEIVED THE MASKS ON 5/8/2020. UPON INSPECTION I NOTICED THAT THE PACKAGE DID NOT LIST WHO MANUFACTURED IT OR WHERE IT WAS MANUFACTURED. THE "FDA" APPROVAL WAS WRITTEN LARGER THAN (B)(6). I OPENED 1 PACK AND THE MASKS HAVE MANY HOLES IN THEM WITH A SEE-THRU EXTREMELY THIN BARRIER, I FELT SOMETHING WAS WRONG AND I CONTACTED THE COMPANY. (B)(4) SAID FOSHAN FLYING MEDICAL PRODUCTS CO. LTD MADE THE MASKS. ON (B)(6) 2020 I CALLED THE FDA AT (B)(6) AND SPOKE TO (B)(6) WHO CHECKED AND SAID FOSHAN FLYING MEDICAL PRODUCTS CO. LTD IS NOT ON THE FDA EUA APPROVED LIST, IT IS NOT ON THE NIOSH APPROVED LIST, AND IT IS NOT ON THE (CDC) NON NIOSH EM LIST. (B)(6) SAID THE MASKS ARE NOT FDA APPROVED AND I SHOULD MAKE THIS REPORT TO THE FDA. I PURCHASED THESE 6 MASKS COSTING (B)(6) BECAUSE (B)(6) SAID THEY WERE FDA APPROVED AND THEY ARE NOT. FDA SAFETY REPORT ID# (B)(4).