BRS Receives 510(k) Clearance from the US Food and Drug Administration for Surgical Masks
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RICHMOND, VA., March 30, 2021 (GLOBE NEWSWIRE) -- via InvestorWire – Blackbriar Regulatory Services, LLC (BRS), a firm specializing in helping small to mid-sized 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. 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. BRS is one of fewer than 50 U.S. manufacturers to receive a 510(k) authorization for surgical masks since 1977. BRS utilized its own regulatory team to develop the successful application, which shows BRS meets the most rigorous and recently updated FDA standards of performance and biocompatibility for masks.
“When the COVID-19 outbreak began last year, we quickly ramped up our manufacturing capabilities to help U.S. frontline workers with the domestic face mask shortage,” said Russ Rogers, CEO of BRS. “In addition to helping our frontline workers, I am extremely proud that we created numerous new American jobs doing important work during a very uncertain time in our nation.”
BRS manufactures competitively priced Level 1 through Level 3 three-ply surgical masks and Level 3 four-ply surgical masks that conform to rigorous American Society for Testing and Materials (ASTM) standards and have undergone extensive third-party biocompatibility testing. BRS masks are made in the USA in a registered FDA medical device facility utilizing U.S. produced meltblown filtration media.
“We are investing in face mask production for the long term, and plan to be part of the solution for ending the current pandemic and preparing the U.S. to be more self-sufficient for the next similar challenge,” said Rogers. “Customers can expect the highest quality USA made product and almost immediate shipment of their orders, and we look forward to manufacturing additional medical devices in the future. BRS has the bandwidth to exponentially expand current face mask production based on customer needs and demand.”
About Blackbriar Regulatory Services, LLC
Blackbriar Regulatory Services specializes in helping small to mid-sized domestic and international companies navigate the regulatory landscape to bring their U.S. Food and Drug Administration (FDA) regulated product concepts to market. Since its inception, BRS has perfected processes in cost efficient manufacturing, analytical testing, regulatory compliance audits and filings, rigorous project management, packaging design, and product stewardship for international customers from the United States, Europe and Asia. BRS prides itself on speed and flexibility, while never compromising quality or their customers’ confidential information. Learn more at www.bb-rs.com and https://bb-rs.com/2021/03/510k/.
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