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510(k) Data Aggregation

    K Number
    K980210
    Device Name
    VARIOUS SURGICAL OR PATIENT DRAPES
    Manufacturer
    GEL-LITE, L.L.C.
    Date Cleared
    1998-05-15

    (114 days)

    Product Code
    KKX
    Regulation Number
    878.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    GEL-LITE, L.L.C.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The various surgical or patient drapes manufactured by DEKA Medical, Inc., consist of natural or synthetic materials intended to be used as a protective patient covering during surgical procedures. The primary purpose of the drapes is to isolate a site of surgical incision from microbial or other contamination.
    Device Description
    DEKA Medical, Inc., will market Surgical Drapes composed of nonwoven fabric or polyethylene film and are of various configurations appropriate for Otological, Ophthalmic, Heart & Neurological, Peri/OB, Arthroscopic, and Specialty Procedures. These devices use nonwoven and film materials as a protective patient covering during surgical procedures. These barrier materials are essentially impervious to fluid transfer across them, thus function to isolate the operative site from the surrounding area. Drapes may feature tape adhesive to temporarily bind the drape to the periphery of the operative site. Fluid collection pouches are attached to the drape for collection of operative wound solid and liquid effluents. The DEKA Medical Surgical Drapes will be subjected to a sterilizing dose of gamma radiation sufficient to achieve a Sterility Assurance Level (SAL) of 10-6.
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