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510(k) Data Aggregation

    K Number
    K203685
    Device Name
    Disposable Surgical Face Mask
    Date Cleared
    2021-03-26

    (99 days)

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

    **Xiantao Zhongyi Safety **& Protection Products Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Disposable Surgical Face Masks (model: ZYD-02&ZYD-03) are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This a single use, disposable device(s), provided non-sterile.
    Device Description
    Disposable Surgical Face Mask Model No.: ZYD-02 and ZYD-03
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