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510(k) Data Aggregation

    K Number
    K211182
    Device Name
    H2H Powder Free Examination Blue Glove
    Manufacturer
    NTL Innovation Co., Ltd.
    Date Cleared
    2021-08-01

    (103 days)

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

    NTL Innovation Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The H2H Powder Free Nitrile Examination Blue Gloves are disposable devices intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner.
    Device Description
    H2H Powder Free Nitrile Examination Blue Gloves
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