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

    STAT(TM) GLOVE

    K Number: K905177 · Decision Jan 30, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    269
    Registration Numbers
    269
    Same Product Code
    78
    Applicant Total
    2
    Review Days
    72

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    Basic Information

    Device Name
    STAT(TM) GLOVE
    K Number
    K905177
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Success Builders Intl., Inc.
    Date Received
    November 19, 1990
    Decision Date
    January 30, 1991
    Product Code
    LZC
    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
    LZC Medical Glove, Specialty

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    Other Clearances by Success Builders Intl., Inc.

    K Number Device Name
    K905127 LATEX GLOVE APPLICATION AND REMOVAL SYSTEM