NetworkNewsBreaks – Blackbriar Regulatory Services LLC Secures FDA 510(k) Clearance for Surgical Masks
Blackbriar Regulatory Services (“BRS”), a firm that assists domestic and international companies navigate the regulatory landscape to bring their U.S. Food and Drug Administration (“FDA”) regulated product concepts to market, has recently received FDA 510(k) clearance for its surgical three- and four-ply masks. According to the update, the 510(k) certification grants BRS the marketing authorization needed to provide the healthcare community and patients with high quality U.S.-made surgical masks to protect from the transfer of microorganisms, body fluids and particulate material. “When the COVID-19 outbreak began last year, we quickly ramped up our manufacturing capabilities to help U.S. frontline workers…
