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

    EXTRA-CARE POWDER-FREE EXAMINATION GLOVE

    K Number: K983175 · Decision Oct 13, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    5
    Review Days
    33

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    Basic Information

    Device Name
    EXTRA-CARE POWDER-FREE EXAMINATION GLOVE
    K Number
    K983175
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ultrawin Sdn Bhd
    Date Received
    September 10, 1998
    Decision Date
    October 13, 1998
    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 Ultrawin Sdn Bhd

    K Number Device Name
    K090828 NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES
    K072802 SINGLE USE, DISPOSABLE, BLUE COLOR, POWDER FREE LATEX PATIENT EXAMINATION GLOVE
    K992175 EXTRA-CARE LATEX PATIENT EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED
    K920059 ULTRASAFE