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

    FLAVORED LATEX PATIENT EXAMINATION

    K Number: K960315 · Decision Nov 20, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    11
    Review Days
    302

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    Basic Information

    Device Name
    FLAVORED LATEX PATIENT EXAMINATION
    K Number
    K960315
    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
    January 23, 1996
    Decision Date
    November 20, 1996
    Product Code
    LYY
    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
    LYY Latex Patient Examination Glove

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    Other Clearances by P.T. Irama Dinamika Latex

    K Number Device Name
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    K965155 LATEX EXAM GLOVES
    K962518 NITRILE COPOLYMER PATIENT EXAMINATION GLOVES
    K963771 CHLOROPRENE EXAM GLOVES
    K953462 PATIENT EXAMINATION GLOVES
    K941787 LATEX EXAM GLOVES
    K913776 PATIENT EXAMINATION GLOVES
    Search all 11 clearances from P.T. Irama Dinamika Latex →