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

    FLEXISKIN POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE

    K Number: K051987 · Decision Oct 6, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    4
    Review Days
    76

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    Basic Information

    Device Name
    FLEXISKIN POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE
    K Number
    K051987
    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
    July 22, 2005
    Decision Date
    October 6, 2005
    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
    K042239 FLEXISKIN POWDER FREE NITRILE EXAMINATION GLOVES, NON STERILE
    K031754 FLEXISKIN POWDER FREE LATEX EXAMINATION GLOVES, NON STERILE
    K031020 FLEXISKIN LATEX EXAMINATION GLOVES, POWDERED, NON STERILE