RAZER ZEPHYR WEARABLE AIR PURIFIER

Description of Event or Problem

THE RAZER ZEPHYR MASK IS MARKETED AS A PERSONAL AIR FILTRATION DEVICE, WITH N-95 GRADE FILTERS. UNFORTUNATELY. THE MASK HAS A DESIGN FLAW WHERE THE SILICONE FACE SEAL MEETS THE BODY OF THE MASK AND NO SEAL IS MADE TO THE MASK, LEAVING AN AIR GAP WHERE UNFILTERED AIR CAN ENTER/LEAVE. THIS DESIGN FLAW IS DUE TO THE FACT THAT THE SILICONE FACE SEAL IS REMOVABLE AND THE BASE IS MADE OF HARD PLASTIC WHICH ATTACHES MAGNETICALLY TO THE BODY OF THE MASK. THIS CREATES AN EQUIDISTANT AIR GAP ALL AROUND THE SILICONE SEAL, NO MATTER HOW MUCH PRESSURE IS PUT TO SEAL IT TO THE FACE. GIVEN THAT AIR TAKES THE PATH OF LEAST RESISTANCE, IT EXITS AND ENTERS/THROUGH THIS GAP INSTEAD OF THROUGH THE OPENINGS WITH THE FILTERS, WHICH OFFER MUCH MORE RESISTANCE. THIS CREATES A CLEAR SAFETY ISSUE, ESPECIALLY FOR A PRODUCT MARKETED AS A SAFETY DEVICE TO PROTECT AGAINST CONTAMINANTS IN THE AIR. I HAVE CONTACTED THE COMPANY SEVERAL TIMES AND THEY REFUSE TO ACKNOWLEDGE THE ISSUE. I ALREADY REPORTED IT TO THE (B)(6) BUT THEY REFERRED ME TO YOU. RAZER SAYS ON THEIR WEBSITE THAT THIS IS NOT A MEDICAL DEVICE, YET THEY HAVE IT LISTED AS A MEDICAL DEVICE WITH THE FDA (PROPRIETARY NAME: RAZER ZEPHYR, CLASSIFICATION NAME: RESPIRATOR, SURGICAL, PRODUCT CODE: MSH, DEVICE CLASS: 2, REGISTERED ESTABLISHMENT NUMBER: (B)(4)). FDA SAFETY REPORT ID # (B)(4).