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

    FLEXISKIN LATEX EXAMINATION GLOVES, POWDERED, NON STERILE

    K Number: K031020 · Decision May 21, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    4
    Review Days
    51

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    Basic Information

    Device Name
    FLEXISKIN LATEX EXAMINATION GLOVES, POWDERED, NON STERILE
    K Number
    K031020
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pt. Mandiri Inti Buana
    Date Received
    March 31, 2003
    Decision Date
    May 21, 2003
    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 Pt. Mandiri Inti Buana

    K Number Device Name
    K051987 FLEXISKIN POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE
    K042239 FLEXISKIN POWDER FREE NITRILE EXAMINATION GLOVES, NON STERILE
    K031754 FLEXISKIN POWDER FREE LATEX EXAMINATION GLOVES, NON STERILE