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510(k) Data Aggregation

    K Number
    K040793
    Device Name
    FELCARE POWDER FREE, POLYMER COATED LATEX EXAMINATION GLOVES
    Manufacturer
    HL RUBBER PRODUCTS SDN BHD
    Date Cleared
    2004-04-14

    (16 days)

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

    HL RUBBER PRODUCTS SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient
    Device Description
    Powder Free Polymer Coated Latex Examination Glove
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    K Number
    K961634
    Device Name
    NIL - POWDER-FREE LATEX EXAMINATION GLOVES
    Manufacturer
    HL RUBBER PRODUCTS SDN BHD
    Date Cleared
    1997-06-16

    (413 days)

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

    HL RUBBER PRODUCTS SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    Powder-Free Latex Examination Gloves
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    Ask a specific question about this device

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