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

    QTEXX POWDERFREE LATEX EXAMINATION GLOVES

    K Number: K981767 · Decision Jun 11, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    7
    Review Days
    23

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    Basic Information

    Device Name
    QTEXX POWDERFREE LATEX EXAMINATION GLOVES
    K Number
    K981767
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Latexx Partners Bhd.
    Date Received
    May 19, 1998
    Decision Date
    June 11, 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 Latexx Partners Bhd.

    K Number Device Name
    K011792 NON-CHLORINATED, POLYMER COATED POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES
    K011791 POWDER FREE NITRILE EXAMINATION GLOVES, VIOLET COLOR
    K992924 QTEXX, NON-CHLORINATED, POWDER FREE NITRILE EXAMINATION GLOVES, POLYMER-COATED
    K992671 QTEXX PRE-POWDERED NITRILE EXAMINATION GLOVES
    K991462 QTEXX POWDER FREE LATEX EXAMINATION GLOVES, POLYMER COATED
    K981159 PROFLEX POWDER FREE NITRILE EXAMINATION GLOVES