BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    STERILETX POWDER FREE LATEX EXAMINATION GLOVES

    K Number: K915189 · Decision Feb 27, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    6
    Review Days
    101

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    Basic Information

    Device Name
    STERILETX POWDER FREE LATEX EXAMINATION GLOVES
    K Number
    K915189
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Transcorp
    Date Received
    November 18, 1991
    Decision Date
    February 27, 1992
    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 Transcorp

    K Number Device Name
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    K903069 KLEARTEX LATEX SURGICAL GLOVES
    K894569 MEDPRIDE LATEX EXAMINATION GLOVES
    K891120 TEXMED LATEX EXAMINATION GLOVE