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

    SKINGARD TPF/AOSSTEX TPF/SENSIFREE/ESSENTIAL TPF/AMERIGLO TPF LATEX EXAMINATION GLOVES

    K Number: K973615 · Decision May 20, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    1
    Review Days
    239

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    Basic Information

    Device Name
    SKINGARD TPF/AOSSTEX TPF/SENSIFREE/ESSENTIAL TPF/AMERIGLO TPF LATEX EXAMINATION GLOVES
    K Number
    K973615
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Macro Rubber Industrial, Inc.
    Date Received
    September 23, 1997
    Decision Date
    May 20, 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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