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510(k) Data Aggregation

    K Number
    K212203
    Device Name
    Dong Hai Xiang Surgical Mask
    Manufacturer
    Taizhou Donghaixiang Protective Equipment Co., Ltd
    Date Cleared
    2022-04-07

    (267 days)

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

    Taizhou Donghaixiang Protective Equipment Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dong Hai Xiang Surgical Mask is intended for use in healthcare settings, procedures during which a face mask is necessary to protect both patient and healthcare personnel from transfer of body fluids, microorganisms, and particulate material. The device is indicated to be over-the-counter use. adult only. The device is disposable and is indicated for single use. The device is not provided sterile
    Device Description
    The Dong Hai Xiang Surgical Masks are composed of 3-layers and are flat-pleated provided blue color, the mask materials consist of an outer layer (polypropylene), Inner layer (polypropylene), Middle Layer filter (Polypropylene Melt-blown), Ear-loops (Spandex + Nylon, Ear Loops way for wearing) and Nose piece (a Polyethylene + Galvanized Iron wire nosepiece to provide a firm fit over the nose and then to secure the mask over the users' mouth and face). The Dong Hai Xiang Surgical Masks are single use, adult only, disposable device, provided non-sterile.
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