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March 2020 510(K) Clearances | FDA

510(k) NO: K191525(Traditional) ATTN: Brian Smekal PHONE NO : 973 5888980 300 Interpace Parkway, Suite 410 SE DECISION MADE: 04-MAR-20 Parsippany NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE ...

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A: The FDA recognizes that the need by healthcare providers and personnel for personal protective equipment (PPE) such as surgical masks and surgical and isolation gowns, may outpace the supply ...

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Surgical Masks. A surgical mask is a loose-fitting, disposable device that creates a physical barrier between the mouth and nose of the wearer and potential contaminants in the immediate environment.

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Oct 15, 2009 · (2009) Filtration performance of FDA-Cleared surgical masks. Journal International Society Respiratory Protection 26; 54-70. OSHA Video: The Difference Between Respirators and Surgical Masks external icon (scroll down page) The Difference Between Respirators and Surgical Masks. U.S. Department of Labor Video, (2009, December 16).

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COVID-19 Impact: Due to increasing costs of operations during COVID-19 we are implementing a test fee surcharge. Making every effort to ensure continuity of testing operations in this unprecedented environment, we are investing significant resources to manage adjusted lab staff schedules for social distancing, training up staff in high demand areas, using additional facilities, expediting...

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