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2020-9-6 · 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.

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2020-8-30 · During the COVID-19 public health emergency, a face mask for a medical purpose that is intended for use as source control, is not labeled as a surgical mask, and is …

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