BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    COMBOSAFE (EUROPE) AND PROMAX (US) SURGICAL GOWNS

    K Number: K041540 · Decision May 5, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    222
    Registration Numbers
    222
    Same Product Code
    294
    Applicant Total
    23
    Review Days
    331

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    Basic Information

    Device Name
    COMBOSAFE (EUROPE) AND PROMAX (US) SURGICAL GOWNS
    K Number
    K041540
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Standard Textile Co., Inc.
    Date Received
    June 8, 2004
    Decision Date
    May 5, 2005
    Product Code
    FYA
    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
    FYA Gown, Surgical

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    Other Clearances by Standard Textile Co., Inc.

    K Number Device Name
    K241214 ProPel SG3™ Surgical Gown
    K172207 Standard Supreme Sterilization Wrapper
    K162162 Barrier Supreme Sterilization Wrapper
    K060181 COMPE1 1 -PLY SURGICAL GOWNS
    K041653 COMPEL 1-PLY SURGICAL GOWNS; COMPEL ISOLATION GOWNS
    K041539 COMPEL SURGICAL GOWNS
    K041541 COMPEL MLR SURGICAL GOWNS
    K012268 TRIMAX
    K012807 MODIFICATION TO: COMPEL SURGICAL DRAPES
    K010799 COMBOSAFE SURGICAL GOWNS, NON-STERILE (75X REUSABLE)
    Search all 23 clearances from Standard Textile Co., Inc. →