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510(k) Data Aggregation

    K Number
    K201853
    Device Name
    Naton Disposable Surgical Face Mask
    Manufacturer
    Naton Biotechnology (Beijing) Co., Ltd.
    Date Cleared
    2021-04-23

    (291 days)

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

    Naton Biotechnology (Beijing) Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Naton Disposable Surgical Face Mask is 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 the potential exposure to blood and body fluids. This is a single-use, There are 4 types of Naton Disposable Surgical Face Mask: Ear Loops B-1, Tie-on B, Tie-on B-1, which are provided sterile.
    Device Description
    Naton Disposable Surgical Face Mask
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