BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    POWDER FREE LATEX PATIENT EXAMINATION GLOVES WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM OF 50 MICROGRAMS OR LESS

    K Number: K012558 · Decision Sep 17, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    8
    Review Days
    40

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    Basic Information

    Device Name
    POWDER FREE LATEX PATIENT EXAMINATION GLOVES WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM OF 50 MICROGRAMS OR LESS
    K Number
    K012558
    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
    August 8, 2001
    Decision Date
    September 17, 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 Matang Mfg. Sdn. Bhd.

    K Number Device Name
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    K072614 MATANG BLACK, POWDER FREE AND POLYMER COATED LATEX EXAMINATION GLOVE
    K032549 MATANG POWDER-FREE POLYCHLOROPRENE PATIENT EXAMINATION GLOVES
    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