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510(k) Data Aggregation

    K Number
    K140195
    Device Name
    SURGICAL DRAPE
    Manufacturer
    GRIFFITH-LUCAS LLC
    Date Cleared
    2014-09-10

    (226 days)

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

    GRIFFITH-LUCAS LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Surgical Drape is intended for external use only and is used as a protective patient covering, such as to isolate a site of surgical incisions from microbial and other contamination. They are provided sterile using ethylene oxide.
    Device Description
    Surgical drapes are intended to provide protection from microbial and other contamination. The Lucas surgical drapes described in this submission are one-piece, single use disposable sheets designed to provide an absorbent sterile barrier during surgical procedures. The drapes cover the patient and are made of an absorbent nonwoven fabric backed with a protective film that stops fluid strike-through. There are various sizes to meet the surgeon's needs. In general, the surgeon delineates with proposed field of surgery and charges the nursing team with the responsibility of draping the patient suing different types of drapes, with & without fenestration. Lucas surgical drapes are made of nonwoven fabric composes of a three-layer composite comprised of a top layer, middle layer and bottom layer, they passed the industry standard tests that measure fluid and synthetic blood penetration, they are classified as a level 4 device under the AAMI PB 70 for barrier performance.
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