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

    FLEXISKIN POWDER FREE NITRILE EXAMINATION GLOVES, NON STERILE

    K Number: K042239 · Decision Dec 16, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    380
    Registration Numbers
    380
    Same Product Code
    1171
    Applicant Total
    4
    Review Days
    120

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    Basic Information

    Device Name
    FLEXISKIN POWDER FREE NITRILE EXAMINATION GLOVES, NON STERILE
    K Number
    K042239
    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
    August 18, 2004
    Decision Date
    December 16, 2004
    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 Pt. Mandiri Inti Buana

    K Number Device Name
    K051987 FLEXISKIN POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE
    K031754 FLEXISKIN POWDER FREE LATEX EXAMINATION GLOVES, NON STERILE
    K031020 FLEXISKIN LATEX EXAMINATION GLOVES, POWDERED, NON STERILE