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510(k) Data Aggregation

    K Number
    K111464
    Device Name
    PALM-PRO POWDER FREE NITRILE EXAMINATION GLOVES
    Date Cleared
    2012-04-19

    (329 days)

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

    DIPPED PRODUCTS (THAILAND) LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Palm-Pro Powder Free Nitrile Examination Glove is "a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner." (21CFR 880.6250)
    Device Description
    Nitrile latex films form a barrier to body fluids and bloodborne pathogens. The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. Nitrile rubber is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The leaching process removes traces of chemical accelerants that may be chemically irritating. The glove is manufactured in accordance with the requirements of ASTM D6319 and ASTM D5151 requirements.
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    K Number
    K050152
    Device Name
    PALM PRO PREMIUM, MODEL 6PF1 & PALM PRO, MODEL 6PF2, LATEX EXAM GLOVE
    Date Cleared
    2005-02-07

    (14 days)

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

    DIPPED PRODUCTS (THAILAND) LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A powder-free patient examination glove is a disposable device made of natural rubber latex material that may bear a trace amount of glove powder and is intended to be worn on the hand or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
    Device Description
    A non-sterile, disposable, patient examination glove made of natural rubber latex, powder-free, with or without polymer coating.
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