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510(k) Data Aggregation

    K Number
    K212922
    Device Name
    Nitrile Examination Gloves
    Manufacturer
    HSK Medical Apparatus Foshan China Co. LTD
    Date Cleared
    2021-12-10

    (87 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    HSK Medical Apparatus Foshan China Co. LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disposable Nitrile Examination Glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
    Device Description
    The subject device is powder free nitrile examination gloves. The subject device is blue. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.
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