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510(k) Data Aggregation

    K Number
    K222074
    Device Name
    Powder Free Nitrile Examination Gloves (Blue, Black, White and/or Violet Blue), Powder Free Latex Examination Gloves
    Date Cleared
    2022-10-17

    (95 days)

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

    Zibo Langu New Material Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Powder Free Nitrile Examination Gloves, Blue is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. Powder Free Nitrile Examination Gloves, Black is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. Powder Free Nitrile Examination Gloves, White is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. The Powder Free Nitrile Examination Gloves, Violet Blue is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. The Powder Free Latex Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    Not Found
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