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510(k) Data Aggregation

    K Number
    K983570
    Device Name
    GLOVE SEAL D'PRO LATEX EXAMINATION GLOVE
    Manufacturer
    GLOVE SEAL SDN BHD
    Date Cleared
    1999-01-14

    (93 days)

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

    GLOVE SEAL SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Glove Seal D'Pro Latex Examination glove is a disposable patient examination glove that is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner.
    Device Description
    Glove Seal D'Pro Latex Examination Glove, Powdered with 100 mcgm or Less of Total Water Extractable Protein Per Gram
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