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

    GLOVETEX LATEX EXAMINATION GLOVES, POWDERED, BLUE, NON STERILE

    K Number: K030273 · Decision Mar 26, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    6
    Review Days
    58

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    Basic Information

    Device Name
    GLOVETEX LATEX EXAMINATION GLOVES, POWDERED, BLUE, NON STERILE
    K Number
    K030273
    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
    January 27, 2003
    Decision Date
    March 26, 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. Wrp Buana Multicorpora

    K Number Device Name
    K032010 GLOVETEX POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, NON-STERILE
    K032011 GLOVETEX POWDER FREE WHITE NITRILE EXAMINATION GLOVES, NON-STERILE
    K032007 GLOVETEX POWDER FREE LATEX EXAMINATION GLOVES, BLUE, NON-STERILE CONTAINS 50 MCGIN OR LESS OF TOTAL WATER EXTRACTABLE PR
    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)