BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇹🇼 Taiwan

    SUPER GLOVES(R) HYPOALLERGENIC

    K Number: K922495 · Decision Sep 4, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    2
    Review Days
    100

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    Basic Information

    Device Name
    SUPER GLOVES(R) HYPOALLERGENIC
    K Number
    K922495
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Taiping Super Holdings Sdn Bhd
    Date Received
    May 27, 1992
    Decision Date
    September 4, 1992
    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 Taiping Super Holdings Sdn Bhd

    K Number Device Name
    K931861 AID, PROMISE POWDER FREE LATEX EXAMINATION GLOVES