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510(k) Data Aggregation

    K Number
    K980511
    Device Name
    NITRILE EXAMINATION GLOVES - POWDER FREE
    Manufacturer
    INFLUX PACIFIC SDN. BHD.
    Date Cleared
    1998-03-13

    (31 days)

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

    INFLUX PACIFIC SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSES THAT IS WORN ON THE EXIMINER'S HAND OR FINGER TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER
    Device Description
    NITRILE EXAMINATION GLOVES -POWDER FREE
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    K Number
    K970216
    Device Name
    NITRILE EXAMINATION GLOVES-PRE POWDERED
    Manufacturer
    INFLUX PACIFIC SDN. BHD.
    Date Cleared
    1997-09-26

    (253 days)

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

    INFLUX PACIFIC SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    NITRILE EXAMINATION GLOVES ( POWDERED
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