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510(k) Data Aggregation

    K Number
    K073299
    Device Name
    BLUE LATEX EXAM GLOVES NON STERILE CHLORINATED POWDER FREE
    Manufacturer
    Date Cleared
    2008-03-05

    (103 days)

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

    BETELCARE SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A patient examination gloves is a disposable device intended for medical purposes worm on the examiner, s hand to prevent contamination between patient and examiner. This gloves is intended for medical and dental use.
    Device Description
    Powder Free Latex Exam gloves Blue
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    K Number
    K000650
    Device Name
    BETEL POWDER FREE LATEX EXAM GLOVES
    Manufacturer
    Date Cleared
    2000-04-20

    (52 days)

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

    BETELCARE SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K000652
    Device Name
    BETEL POWDER FREE LATEX EXAM GLOVES, CHLORINATED, WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
    Manufacturer
    Date Cleared
    2000-04-10

    (42 days)

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

    BETELCARE SDN BHD

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