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

    NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES

    K Number: K090828 · Decision Jul 28, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    380
    Registration Numbers
    380
    Same Product Code
    1171
    Applicant Total
    5
    Review Days
    124

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    Basic Information

    Device Name
    NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES
    K Number
    K090828
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ultrawin Sdn Bhd
    Date Received
    March 26, 2009
    Decision Date
    July 28, 2009
    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 Ultrawin Sdn Bhd

    K Number Device Name
    K072802 SINGLE USE, DISPOSABLE, BLUE COLOR, POWDER FREE LATEX PATIENT EXAMINATION GLOVE
    K992175 EXTRA-CARE LATEX PATIENT EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED
    K983175 EXTRA-CARE POWDER-FREE EXAMINATION GLOVE
    K920059 ULTRASAFE