Defender Safety, a trusted construction, and healthcare safety products producer, recently received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its ASTM Level 1 Procedure Mask, ASTM Level 3 Procedure Mask, and ASTM Level 3 Surgical Mask. The 510(k) certification is yet another recognition of the high standards that have led countless businesses, healthcare facilities, and professionals to turn to Defender Safety surgical masks for protection against the transfer of microorganisms and particulate matter.
“Last February, as COVID made its way to the U.S. and a face mask shortage started to develop, we mobilized quickly, but responsibly. Ensuring our PPE is medical-grade for those that need it most has always been a top priority,” said Teddy Haggerty, Founder, and CEO of Defender Safety. “Receiving our 510(k) clearance is a great validator of the team’s dedication to developing a product that not only meets the needs of this moment but can serve as the choice PPE supply of the healthcare industry for years to come.”
Defender Safety surgical masks are tested in performance for bacterial filtration efficiency, resistance to penetration by synthetic blood, breathability, and flammability. The surgical masks consistently met the 510(k) standard in all areas. The ASTM Procedure Mask Level 3 and ASTM Surgical Mask Level 3 have a bacterial filtration efficiency (BFE) of ≥98% and the ASTM Procedure Mask Level 1 has a bacterial filtration efficiency (BFE) of ≥95%.
Defender Safety has supplied over 50 million pieces of PPE — medical-grade masks, gloves, disinfectants, and goggles — to over 70 hospitals and other public entities across the northeast, including Mass General Brigham, companies such as Fastenal and W.W. Grainger, and local governments including New York State.
About Defender Safety is a developer and distributor of healthcare and industrial PPE. Beginning in 2018 with the development of hard hats that set a new standard for construction safety and quality, the New York-based company has continued to innovate and expand its product lines to include products such as surgical masks, nitrile gloves, fall protection kits, safety goggles, and more.