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

    EUDERMIC PF POWDER-FREE SURGICAL GLOVES

    K Number: K001343 · Decision Jun 12, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    2
    Review Days
    46

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    Basic Information

    Device Name
    EUDERMIC PF POWDER-FREE SURGICAL GLOVES
    K Number
    K001343
    Device Class
    FDA class 1
    Clearance Type
    Abbreviated
    Regulation Number
    878.4460
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Maxxim Medical, Inc.
    Date Received
    April 27, 2000
    Decision Date
    June 12, 2000
    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 Maxxim Medical, Inc.

    K Number Device Name
    K011198 SENICARE ADVANTIX POWDER FREE POLYURETHANE MEDICAL EXAMINATION GLOVE, SENSICARE ADVANTIX POWDER FREE POLYURETHANE DENTAL