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  • Premarket Notification 510(k) FDA

    See more on fda.gov

  • 510(k) Premarket Notification

    Device Classification Namerespirator, surgical510(k) NumberK974068Device NamePFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL

  • 510(k) Premarket Notification accessdata.fda.gov

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  • FDA Approved Surgical Masks Pasture Group

    FDA 510(k):K141875. US FDA APROVAL Class II FDA Classification PanelGeneral and Plastic Surgery. Bacterial Filtration Efficiency (BFE) 99.76% with 3.0m, bio aerosol particles Particulate Filtration Efficiency (PFE) 99% for particles at 0.1m Differential Pressure (DP)3.33mm H2O/cm2 Breathability (DP)Ezy Breathe Technology Fluid ResistanceResists Synthetic Blood @ 80mm Hg

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  • Medical Gowns FDA

    Surgical Gowns. A surgical gown is regulated by the FDA as a Class II medical device that requires a 510(k) premarket notification. A surgical gown is a personal protective garment intended to be

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  • Surgical Face Masks

    Product Title 10 Pack Disposable Face Masks, 3 Ply, Single Use, with Ear loops Average rating4.5 out of 5 stars, based on 16 reviews 16 ratings Current Price $14.99 $ 14 . 99

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  • 10 Best Disposable Masks For Coronavirus

    Mar 07, 2020 · This pack of 50 FDA approved masks is made with standard medical grade material that prevents the passage of dust, pollen or other tiny microbes from entering your mouth or nose. The mask is made with a 3 ply sheet ensuring that the air your breath is fresh and safe.

  • Surgical Face Masks

    Product Title 10 Pack Disposable Face Masks, 3 Ply, Single Use, with Ear loops Average rating4.5 out of 5 stars, based on 16 reviews 16 ratings Current Price $14.99 $ 14 . 99

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