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510(k) Data Aggregation

    K Number
    K210518
    Device Name
    Surgical Face Mask
    Date Cleared
    2021-06-14

    (111 days)

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

    Shandong Haidike Medical Products Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Surgical Face Mask is intended for single use by operation room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.
    Device Description
    The proposed device, Surgical Face Mask is a three-layer, single-use, flat-pleated mask. The mask body is made of 25g/m² PP non-woven cloth. The mask contains tie strings or ear loops to secure the mask over the users' mouth and face and includes a nosepiece to provide a firm fit over the nose. Ear loops are made of Nylon and Spandex, and tie strings are made of 25g/m² PP non-woven cloth. The nose clip which is made of high-density polyethylene and Galvanized wire. The device is provided in sterile.
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