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510(k) Data Aggregation

    K Number
    K043015
    Device Name
    3L SURGICAL DRAPES
    Date Cleared
    2005-08-15

    (286 days)

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

    3L MEDICAL PRODUCTS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    3L. Surgical Drapes described in this submission are intended to be used to provide an isolating barrier during surgical procedures. The drapes cover the patient and are made of plastic with a protective film that stops fluid strike-through. The drapes submitted provide an isolator as a vertical barrier to keep the C-arm from the surgical field during hip/femur fracture or trauma procedures, or create a isolating barrier during orthopedic procedures, or provide secure adhesion on drapes for general use, or meet surgical minor procedural needs, or give a sterile surface all of the way to the wound.
    Device Description
    3L® Surgical Drapes are made from PE or PU sheets with adhesive strips, sterilized or nonsterilized. They provide an isolating barrier during surgical procedures to cover the patients and stops fluid strike-through.
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