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510(k) Data Aggregation

    K Number
    K061551
    Device Name
    POWDER FREE LATEX EXAMINATION GLOVES, NATURAL OR BLUE COLOUR AND WITH PROTEIN CONTENT LABELING CLAIM (50 UG OR LESS)
    Date Cleared
    2006-08-24

    (80 days)

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

    MEDIPURE CORPORATION (M) SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Powder Free Latex Examination Glove is a disposable device made of natural rubber latex that may bear a trace amount of glove powder and is intended to be worn on hands or finger(s) for medical purposes to provide a barrier.against potentially infectious materials and other contaminants.
    Device Description
    The Powder Free Latex Examination Gloves. Natural or Blue Colour and with Protein Content Labeling Claim is equivalent to the exiting model, i.e. Latex Patient Examination Gloves. Powder Free which had submitted and cleared under 510(k) number K924356. The differences in this submission are: - With or without colour additive upon customers` preference or request. a) - With protein content labeling claim, i.e. "This latex glove contains 50 micrograms or b) less of total water extractable protein per gram``.
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    K Number
    K001165
    Device Name
    POLYMER COATED POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
    Date Cleared
    2000-07-05

    (86 days)

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

    MEDIPURE CORPORATION (M) SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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