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The FDA regulates surgical masks and surgical N95 respirators differently based on their intended use. A surgical mask is a loose-fitting, disposable device that creates a physical barrier between ce fda certificate face mask n95 maskNIOSH Certification for N95 Respirator I3CGlobalSep 21, 2020 · Surgical N95 Respirator Face Mask under FDA Product Code MSH must undergo NIOSH Certification prior to FDA 510k application and clearance. General N95 face mask (without Virus Bacteria protection claim) under product code MSH can be directly registered and listed without 510k and NIOSH. More information about FDA 510k >>Personal Protective Equipment EUAs FDAFace Masks and Surgical Masks for COVID-19 Manufacturing, Purchasing, Importing, and Donating Masks During the Public Health Emergency Content current as of 08 26 2020
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