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

    LATEX EXAMINATION GLOVES-POWDERED, NONSTERILE

    K Number: K010347 · Decision Mar 27, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    2
    Review Days
    50

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    Basic Information

    Device Name
    LATEX EXAMINATION GLOVES-POWDERED, NONSTERILE
    K Number
    K010347
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Enzymic Technologies Sdn Bhd
    Date Received
    February 5, 2001
    Decision Date
    March 27, 2001
    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 Enzymic Technologies Sdn Bhd

    K Number Device Name
    K010356 LATEX EXAMINATION GLOVES-POWDER FREE