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

    REGAL LATEX SURGICAL GLOVES

    K Number: K881191 · Decision Apr 1, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    2
    Review Days
    11

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    Basic Information

    Device Name
    REGAL LATEX SURGICAL GLOVES
    K Number
    K881191
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4460
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Maxcare, Inc.
    Date Received
    March 21, 1988
    Decision Date
    April 1, 1988
    Product Code
    KGO
    Advisory Committee
    General, Plastic Surgery
    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
    KGO Surgeon'S Gloves

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    Other Clearances by Maxcare, Inc.

    K Number Device Name
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