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

    POWDER FREE NITRILE EXAMINATION GLOVE-BLUE (CHEMOTHERAPY)

    K Number: K122131 · Decision Oct 17, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    380
    Registration Numbers
    380
    Same Product Code
    1171
    Applicant Total
    8
    Review Days
    91

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    Basic Information

    Device Name
    POWDER FREE NITRILE EXAMINATION GLOVE-BLUE (CHEMOTHERAPY)
    K Number
    K122131
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Matang Mfg. Sdn. Bhd.
    Date Received
    July 18, 2012
    Decision Date
    October 17, 2012
    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 Matang Mfg. Sdn. Bhd.

    K Number Device Name
    K121368 NITRILE EXAMINATION GLOVE, POWDER FREE (BLUE, BLACK OR WHITE)
    K072614 MATANG BLACK, POWDER FREE AND POLYMER COATED LATEX EXAMINATION GLOVE
    K032549 MATANG POWDER-FREE POLYCHLOROPRENE PATIENT EXAMINATION GLOVES
    K012558 POWDER FREE LATEX PATIENT EXAMINATION GLOVES WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM OF 50 MICROGRAMS OR LESS
    K000985 MATANG POWDERED LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS
    K982877 MATANG POWDER-FREE LOW PROTEIN LATEX PATIENT EXAMINATION GLOVE
    K896094 LATEX EXAMINATION GLOVES