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

    ECLIPSE LATEX POWDER FREE STERILE SURGEON'S GLOVE

    K Number: K050533 · Decision Apr 26, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    7
    Review Days
    55

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    Basic Information

    Device Name
    ECLIPSE LATEX POWDER FREE STERILE SURGEON'S GLOVE
    K Number
    K050533
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4460
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Regent Medical Americas, LLC
    Date Received
    March 2, 2005
    Decision Date
    April 26, 2005
    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 Regent Medical Americas, LLC

    K Number Device Name
    K053441 BIOGEL LATEX POWDER FREE STERILE SURGEON'S GLOVE
    K053102 BIOGEL SKINSENSE POWDER-FREE NON-LATEX SURGEON'S GLOVE
    K053442 BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVE
    K053443 BIOGEL ECLIPSE NON-PYROGENIC LATEX POWDER-FREE STERILE SURGEON'S GLOVE
    K050899 BIOGEL LATEX STERILE POWDER-FREE GLOVE
    K050184 BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVE