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

    POWDERED LATEX EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE

    K Number: K081040 · Decision May 20, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    7
    Review Days
    39

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    Basic Information

    Device Name
    POWDERED LATEX EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE
    K Number
    K081040
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Pt.Shamrock Manufacturing Corp.
    Date Received
    April 11, 2008
    Decision Date
    May 20, 2008
    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 Pt.Shamrock Manufacturing Corp.

    K Number Device Name
    K052709 POWDER FREE LATEX EXAMINATION GLOVES, SIZES SMALL, MEDIUM, LARGE, X-LARGE
    K052382 POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
    K030325 POWDERFREE LATEX EXAMINATION GLOVES WITH BUBBLEGUM
    K030134 LATEX EXAMINATION GLOVES POWDER FREE WITH NEOPRENE LINED, SIZES XSMALL, SMALL, MEDIUM, LARGE, XLARGE
    K030560 POWDERFREE LATEX EXAMINATION GLOVES WITH GRAPE
    K011712 LATEX EXAMINATION GLOVES- POWDER FREE, BLUE