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

    ALATECH POWDER FREE LATEX EXAMINATION GLOVE

    K Number: K083761 · Decision Jul 22, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    4
    Review Days
    216

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    Basic Information

    Device Name
    ALATECH POWDER FREE LATEX EXAMINATION GLOVE
    K Number
    K083761
    Device Class
    FDA class 1
    Clearance Type
    Abbreviated
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Alatech Healthcare, LLC
    Date Received
    December 18, 2008
    Decision Date
    July 22, 2009
    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 Alatech Healthcare, LLC

    K Number Device Name
    K082529 ALATECH CHAMPION VYTEX LUBRICATED MALE LATEX CONDOM
    K080606 ALATECH POWDERED LATEX PATIENT EXAMINATION GLOVE
    K993887 ALATECH LATEX CONDOM