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 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.”
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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 its customers’ confidential information. Learn more at www.bb-rs.com and https://bb-rs.com/2021/03/510k/.
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