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510(k) Data Aggregation

    K Number
    K203704
    Device Name
    Surgical face mask
    Date Cleared
    2021-06-04

    (168 days)

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

    Juntech(Jiaxing)Healthcare Materials Co,.Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Surgical Face Mask is intended for single use by operating 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
    Surgical Face Mask is single use multi-layer mask with outer layer and inner layer (spun-bond polypropylene) that sandwich a meltblown polypropylene filter material. Earloops are of urethane elastic fiber and not made with natural rubber latex; The nose piece is a white aluminum strip covered by PP covering. All of the materials used in the construction of the surgical mask are being used in currently marketed devices.
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