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

    GLOVETEX POWDER FREE WHITE NITRILE EXAMINATION GLOVES, NON-STERILE

    K Number: K032011 · Decision Aug 19, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    380
    Registration Numbers
    380
    Same Product Code
    1171
    Applicant Total
    6
    Review Days
    50

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    Basic Information

    Device Name
    GLOVETEX POWDER FREE WHITE NITRILE EXAMINATION GLOVES, NON-STERILE
    K Number
    K032011
    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. Wrp Buana Multicorpora
    Date Received
    June 30, 2003
    Decision Date
    August 19, 2003
    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. Wrp Buana Multicorpora

    K Number Device Name
    K032010 GLOVETEX POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, NON-STERILE
    K032007 GLOVETEX POWDER FREE LATEX EXAMINATION GLOVES, BLUE, NON-STERILE CONTAINS 50 MCGIN OR LESS OF TOTAL WATER EXTRACTABLE PR
    K030273 GLOVETEX LATEX EXAMINATION GLOVES, POWDERED, BLUE, NON STERILE
    K022343 GLOVETEX POWDER FREE LATEX EXAMINATION GLOVES, NON STERILE (PROTEIN CONTENT LABELING CLAIM 50UG/G OR LESS)
    K994426 GLOVETEX, LATEX EXAMINATION GLOVES, POWDERED NON-STERILE.(PROTEIN CONTENT LABELING)