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510(k) Data Aggregation

    K Number
    K211771
    Device Name
    The GOOD High Fluid-Resistant Surgical Mask, The GOOD High Fluid-Resistant Surgical Procedure KF Mask, The GOOD Super Guard Design High Fluid-Resistant Surgical Mask, The KOEASY High Fluid-Resistant Surgical Mask, The KOEASY High Fluid-Resistant Surgical Procedure KF Mask, The KOEASY Super Guard Design High Fluid-Resistant Surgical Mask
    Date Cleared
    2022-08-24

    (442 days)

    Product Code
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    The GOOD Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The GOOD High Fluid-Resistant Surgical Mask and the KOEASY High Fluid-Resistant Surgical Mask are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. The face mask is single use, disposable device, provided non-sterile.
    Device Description
    The subject device includes six mask models. Each mask is composed of four-layers (outer non-woven layer, support layer, melt blown filter layer, and inner non-woven layer). Each mask contains ear loops to secure the mask over the users' mouth and face and includes a malleable nosepiece to provide a firm fit over the nose. The masks are single use, disposable devices, provided non-sterile. These devices are not made from Natural Rubber Latex.
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