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510(k) Data Aggregation

    K Number
    K970115
    Device Name
    POWDER FREE LATEX EXAMINATION GLOVES
    Manufacturer
    PT MBF BUANA MULTICORPORA
    Date Cleared
    1997-08-15

    (214 days)

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

    PT MBF BUANA MULTICORPORA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Glove worn on hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
    Device Description
    Not Found
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