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

    SMARTTEX PREPOWDERED LATEX EXAMINATION GLOVES

    K Number: K981348 · Decision May 18, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    27
    Review Days
    38

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    Basic Information

    Device Name
    SMARTTEX PREPOWDERED LATEX EXAMINATION GLOVES
    K Number
    K981348
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Smart Glove Corp. Sdn Bhd
    Date Received
    April 10, 1998
    Decision Date
    May 18, 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 Smart Glove Corp. Sdn Bhd

    K Number Device Name
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    K082370 POWDER FREE NITRILE EXAMINATION GLOVE (BLUE)
    K081466 STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
    K071170 POWDER FREE NITRILE EXAMINATION GLOVES, MAGENTA AND WHITE COLOR COATED WITH ALLOGEL
    K063627 POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE)
    K061724 POWDER FREE NITRILE EXAMINATION GLOVE, GRAPE SCENTED (BLUE AND WHITE)
    K060726 POWDER FREE NITRILE EXAMINATION GLOVE COATED WITH CUCUMBER WITH GLYCERINE (BLUE COLOR)
    K060724 POWDER FREE NITRILE EXAMINATION GLOVE (BLACK AND GRAY)
    K050122 POWDER FREE NITRILE EXAMINATION GLOVE (BLUE) (THIS PRODUCT DOES NOT CONTAIN THIURAM, AND/OR CARBAMATE AND/OR THIAZOLE)
    K050598 POWDER FREE NITRILE EXAMINATION GLOVE WITH TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM (BLUE)
    Search all 27 clearances from Smart Glove Corp. Sdn Bhd →