LogoFDA 510(k) Search
Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K982131
    Device Name
    NITRA-TOUCH POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE
    Manufacturer
    ANSELL EDMONT INDUSTRIAL, INC.
    Date Cleared
    1998-10-29

    (134 days)

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

    ANSELL EDMONT INDUSTRIAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A disposable device intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner and for use handling chemotherapy drugs.
    Device Description
    Nitra-Touch™ examination gloves are disposable device intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner and for use handling chemotherapy drugs.
    Ask a Question

    Ask a specific question about this device

    K Number
    K965095
    Device Name
    NITRA-TOUCH POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE
    Manufacturer
    ANSELL EDMONT INDUSTRIAL, INC.
    Date Cleared
    1997-04-22

    (124 days)

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

    ANSELL EDMONT INDUSTRIAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Nitra-Touch™ examination gloves are disposable device intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner.
    Device Description
    Nitra-Touch™ examination gloves
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1