BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇻🇳 Vietnam

    POWDER FREE LATEX EXAMINATION GLOVES

    K Number: K033533 · Decision Jun 24, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    2
    Review Days
    227

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    Basic Information

    Device Name
    POWDER FREE LATEX EXAMINATION GLOVES
    K Number
    K033533
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Apl International Incorporated Limited
    Date Received
    November 10, 2003
    Decision Date
    June 24, 2004
    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 Apl International Incorporated Limited

    K Number Device Name
    K033531 POWDERED LATEX EXAMINATION GLOVES