BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇦 Canada

    MED.EXAM.GLOVES POWDERED ANATOMICALLY CORRECT

    K Number: K915127 · Decision Feb 11, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    2
    Review Days
    90

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    Basic Information

    Device Name
    MED.EXAM.GLOVES POWDERED ANATOMICALLY CORRECT
    K Number
    K915127
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Hedd Roz Canada, Inc.
    Date Received
    November 13, 1991
    Decision Date
    February 11, 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 Hedd Roz Canada, Inc.

    K Number Device Name
    K915126 LATEX MED.EXAM.GLOVES POWDERED AMBIDEXTROUS