BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇦 Canada

    ELASTYREN(R) SURGICAL GLOVES

    K Number: K945833 · Decision Jan 17, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    9
    Review Days
    49

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    ELASTYREN(R) SURGICAL GLOVES
    K Number
    K945833
    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
    Eci Medical Technologies, Inc.
    Date Received
    November 29, 1994
    Decision Date
    January 17, 1995
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (KGO), ordered by most recent decision date.

    Sterile Latex Powder Free Surgical Gloves

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    Polyisoprene Surgical gloves

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green); Natural Rubber Latex (Strip&Coat)/(Strip&Pack) Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX PI Hybrid Micro (340002065); GAMMEX PI Hybrid Micro (340002070); GAMMEX PI Hybrid Micro (340002075); GAMMEX PI Hybrid Micro (340002080); GAMMEX PI Hybrid Micro (340002085); GAMMEX PI Hybrid Micro (340002090)

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery
    View all

    Other Clearances by Eci Medical Technologies, Inc.

    K Number Device Name
    K021598 ELASTYLITE SYNTHETIC POWDERED SURGICAL GLOVE
    K020918 ELASTYFREE SYNTHETIC POWDER-FREE SURGICAL GLOVE
    K984337 ELASTYLON POWDER-FREE SURGICAL GLOVE
    K971471 ELASTYREN POWDER-FREE SURGICAL GLOVE
    K970015 ELASTYREN POWDER-FREE PATIENT EXAMINATION GLOVES
    K954533 ELASTYREN HYPOALLERGENIC PATIENT EXAMINATION GLOVES
    K954535 ELASTYREN HYPOALLERGENIC SURGICAL GLOVES
    K946291 ELASTYREN(R) PATIENT EXAMINATION GLOVES