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

    STERILE LATEX POWDER FREE SURGICAL GLOVES WITH HYDROGEL COATING

    K Number: K111015 · Decision May 6, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    26
    Review Days
    25

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    Basic Information

    Device Name
    STERILE LATEX POWDER FREE SURGICAL GLOVES WITH HYDROGEL COATING
    K Number
    K111015
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4460
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cardinal Health, Inc.
    Date Received
    April 11, 2011
    Decision Date
    May 6, 2011
    Product Code
    KGO
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    HO
    Third Party
    Y

    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 Cardinal Health, Inc.

    K Number Device Name
    K170198 Cardinal Health Sterile Polyisoprene Blend Powder-Free Surgical Gloves, Tested for Use with Chemotherapy Drugs (White)
    K160411 Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera Coating
    K160875 Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating
    K153316 Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating and Tested for Use with Chemotherapy Drugs (Yellow)
    K122696 POWDER-FREE NITRILE EXAMINATION GLOVES (COOL BLUE)
    K121897 PROTEXIS LATEX BASIC STERILE POWDER-FREE SURGICAL GLOVES
    K120934 PROTEXIS LATEX BASIC STERILE LATEX POWDER-FREE SURGICAL GLOVE WITH PROTEIN CONTENT LABEL CLAIM OF 50 UG/DM OR LESS
    K111878 PROTEXIS LATEX BLUE WITH NEU-THERA POWDER-FREE SURGICAL GLOVES
    K110272 STERILE POLYISOPRENE POWDER-FREE SURGICAL GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUG
    K110921 NITRILE POWDER-FREE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS
    Search all 26 clearances from Cardinal Health, Inc. →