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

    POWDER-FREE LATEX EXAMINATION GLOVES - 18 MILS AT FINGER, BLUE COLOR; 9 AND 10 MILS AT FINGER, NATURAL COLOR

    K Number: K072197 · Decision Mar 12, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    269
    Registration Numbers
    269
    Same Product Code
    78
    Applicant Total
    2
    Review Days
    218

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    Basic Information

    Device Name
    POWDER-FREE LATEX EXAMINATION GLOVES - 18 MILS AT FINGER, BLUE COLOR; 9 AND 10 MILS AT FINGER, NATURAL COLOR
    K Number
    K072197
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Metacure Surgical Gloves Sdn Bhd
    Date Received
    August 7, 2007
    Decision Date
    March 12, 2008
    Product Code
    LZC
    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
    LZC Medical Glove, Specialty

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    Other Clearances by Metacure Surgical Gloves Sdn Bhd

    K Number Device Name
    K073447 SURGI GLOVES