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

    JAMES RIVER BIOGEL POWDERLESS SURGICAL GLOVES

    K Number: K890459 · Decision Apr 20, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    15
    Review Days
    80

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    Basic Information

    Device Name
    JAMES RIVER BIOGEL POWDERLESS SURGICAL GLOVES
    K Number
    K890459
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4460
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    James River Corp.
    Date Received
    January 30, 1989
    Decision Date
    April 20, 1989
    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 James River Corp.

    K Number Device Name
    K894505 COTOLIN DRAIN SPONGE AND DRESSING SPONGE
    K894147 VISULIN TRANSPARENT ADHESIVE DRESSING
    K893939 ISOLATION MASKS
    K894034 MODIFIED LABELING OF SURGICAL GLOVES
    K892580 CARETOUCH EXAMINATION GLOVES
    K883802 CARETEX CENTRAL SUPPLY WRAP
    K884112 CARETEX OR TOWEL
    K883657 SKID RESISTANT, LONG LASTING SHOE COVERS
    K880431 CARETEX SURGEON'S HOODS
    K880481 CARETEX SURGEON'S CAPS
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