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

    WELLS LAMONT CUT RESISTANT SURGICAL GLOVE LINERS

    K Number: K922407 · Decision Jun 15, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    801
    Registration Numbers
    801
    Same Product Code
    55
    Applicant Total
    4
    Review Days
    390

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    Basic Information

    Device Name
    WELLS LAMONT CUT RESISTANT SURGICAL GLOVE LINERS
    K Number
    K922407
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Wells Lamont Corp.
    Date Received
    May 21, 1992
    Decision Date
    June 15, 1993
    Product Code
    LYU
    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
    LYU Accessory, Surgical Apparel

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    Other Clearances by Wells Lamont Corp.

    K Number Device Name
    K944763 CUT-TEC OR WELLS LAMONT POLYESTER/WIRE CUT-RESISTANT GLOVE LINER WELLS-TEC, SCEPTER
    K940274 NYLON LINER GLOVES
    K925937 WELLS LAMONT HANDAGES/MED WRAP DRESSINGS