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

    NITRILE BLUE POWDER FREE EXAMINATION GLOVE

    K Number: K052956 · Decision Dec 21, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    444
    Registration Numbers
    445
    Same Product Code
    1158
    Applicant Total
    4
    Review Days
    61

    Basic Information

    Device Name
    NITRILE BLUE POWDER FREE EXAMINATION GLOVE
    K Number
    K052956
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    GREAT GLOVE SDN BHD
    Date Received
    October 21, 2005
    Decision Date
    December 21, 2005
    Product Code
    LZA
    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
    LZA Polymer Patient Examination Glove

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    Other Clearances by GREAT GLOVE SDN BHD

    K Number Device Name
    K052955 NITRILE BLUE POWDERED EXAMINATION GLOVES
    K020363 GREAT GLOVE LATEX EXAMINATION POWDERFREE GLOVES WITH PROTEIN LABELLING CLAIMS (50 MICROGRAMS OR LESS)
    K993386 LATEX EXAMINATION POWDERED GLOVES