ReportFDA exempts surgical facemasks from 510k

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ReportFDA exempts surgical facemasks from 510(k . May 18, 2018 · With the order, which was proposed last December, N95 filtering face piece respirators and surgical N95 respirators will be exempt from 510(k) review, with certain limitations, RAPS reports.ce and fda 510k approved cleaning surgical masks size ReportFDA exempts surgical facemasks from 510(k . May 18, 2018 · With the order, which was proposed last December, N95 filtering face piece respirators and surgical N95 respirators will be exempt from 510(k) review, with certain limitations, RAPS reports.