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

    CHLORINATED POWDER FREE NITRILE LATEX EXAMINATION GLOVES

    K Number: K071740 · Decision Oct 4, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    380
    Registration Numbers
    380
    Same Product Code
    1171
    Applicant Total
    4
    Review Days
    99

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    Basic Information

    Device Name
    CHLORINATED POWDER FREE NITRILE LATEX EXAMINATION GLOVES
    K Number
    K071740
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtexx Manufacturing Sdn. Bhd.
    Date Received
    June 27, 2007
    Decision Date
    October 4, 2007
    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 Medtexx Manufacturing Sdn. Bhd.

    K Number Device Name
    K120963 POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES
    K070821 POWDERED NATURAL RUBBER LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) 200 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE
    K070072 NON-CHLORINATED POLYMER COATED POWDER-FREE NATURAL LATEX EXAMINATION GLOVES