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510(k) Data Aggregation

    K Number
    K212011
    Device Name
    Vinyl Powder Free Examination Glove
    Manufacturer
    Top Glove Vietnam Company Limited
    Date Cleared
    2022-02-14

    (231 days)

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

    Top Glove Vietnam Company Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    Vinyl Examination Powder Free Glove
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