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

    TRI-CLEAN 110/TRI-CLEAN PLUS GLOVE

    K Number: K960590 · Decision Oct 31, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    18
    Review Days
    262

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    Basic Information

    Device Name
    TRI-CLEAN 110/TRI-CLEAN PLUS GLOVE
    K Number
    K960590
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Aladan Corp.
    Date Received
    February 12, 1996
    Decision Date
    October 31, 1996
    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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    K942758 HYPOALLERGEN NON-STER POWDERFREE LATEX PAT EXAM GLOVE
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