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510(k) Data Aggregation

    K Number
    K213859
    Device Name
    Stronghold Group Nitrile Examination Glove, Powder Free
    Manufacturer
    Stronghold Group LLC
    Date Cleared
    2022-01-13

    (34 days)

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

    Stronghold Group LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Stronghold Group Nitrile Examination Gloves, Powder Free is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.
    Device Description
    The subject device in this 510(k) Notification is Stronghold Group Nitrile Examination Glove, Powder Free. The subject device is a patient examination glove made from nitrile compound, blue color, powder free and non-sterile (Per 21 CFR 880.6250. Class I). The device meets the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
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