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510(k) Data Aggregation
K Number
K043015Device Name
3L SURGICAL DRAPES
Manufacturer
Date Cleared
2005-08-15
(286 days)
Product Code
Regulation Number
878.4370Why 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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