BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇮🇩 Indonesia

    CHLOROPRENE EXAM GLOVES

    K Number: K963771 · Decision Dec 19, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    380
    Registration Numbers
    380
    Same Product Code
    1171
    Applicant Total
    11
    Review Days
    91

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    Basic Information

    Device Name
    CHLOROPRENE EXAM GLOVES
    K Number
    K963771
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    P.T. Irama Dinamika Latex
    Date Received
    September 19, 1996
    Decision Date
    December 19, 1996
    Product Code
    LZA
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LZA Polymer Patient Examination Glove

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    Other Clearances by P.T. Irama Dinamika Latex

    K Number Device Name
    K984449 NATURAL RUBBER PRE-POWDERED COLORED & FLAVORED PATIENT EXAMINATION GLOVES WITH PROTEIN LABELLING CLAIM
    K981064 POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVES
    K980848 HYPOALLERGENIC LATEX PATIENT EXAM GLOVES-PREPOWDERED
    K972306 POWDERFREE COLORED AND FLAVORED NITRILE COPOLYMER PATIENT EXAMINATION GLOVES-MEDICAL DEVICE
    K965155 LATEX EXAM GLOVES
    K962518 NITRILE COPOLYMER PATIENT EXAMINATION GLOVES
    K960315 FLAVORED LATEX PATIENT EXAMINATION
    K953462 PATIENT EXAMINATION GLOVES
    K941787 LATEX EXAM GLOVES
    K913776 PATIENT EXAMINATION GLOVES
    Search all 11 clearances from P.T. Irama Dinamika Latex →