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

    LATEX EXAMINATION GLOVES

    K Number: K896094 · Decision Jan 17, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    8
    Review Days
    89

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    Basic Information

    Device Name
    LATEX EXAMINATION GLOVES
    K Number
    K896094
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Matang Mfg. Sdn. Bhd.
    Date Received
    October 20, 1989
    Decision Date
    January 17, 1990
    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 Matang Mfg. Sdn. Bhd.

    K Number Device Name
    K122131 POWDER FREE NITRILE EXAMINATION GLOVE-BLUE (CHEMOTHERAPY)
    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