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510(k) Data Aggregation

    K Number
    K962539
    Device Name
    GANTEX MODEL NSG-75PF
    Manufacturer
    AMERICAN PRO LATEX, INC.
    Date Cleared
    1997-07-14

    (381 days)

    Product Code
    KGO
    Regulation Number
    878.4460
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMERICAN PRO LATEX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Our surgeon's gloves are a device intended to be worn by operating room personnel to protect a surgical wound from contamination.
    Device Description
    Gantex Model NSG-75PF Powder Free Surgeon Glove
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