BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇲🇾 Malaysia

    MULTIPLE NAME

    K Number: K123819 · Decision Mar 5, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    5
    Review Days
    83

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    Basic Information

    Device Name
    MULTIPLE NAME
    K Number
    K123819
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Top Calibre Sdn Bhd
    Date Received
    December 12, 2012
    Decision Date
    March 5, 2013
    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 Top Calibre Sdn Bhd

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    K120692 LATEX EXAMINATION GLOVES (POWDER FREE)
    K120693 LATEX EXAMINATION GLOVES (POWDERED)
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