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For the dressing and management of chronic/open wounds.

The AllDress® Multi Layered Wound Dressing is a sterile wound dressing composed of an absorbent layer with a non-adherent wound contact surface. The absorbent layer is bonded to an adhesive backing layer which secures the dressing to the skin around the wound. Dressings are supplied in sizes of 2 ¼ "x 2 ¼ (1"x 1" wound contact surface); 6"x 6" (4"x 4" wound contact surface); 4"x 4" (2"x 2" wound contact surface); and 6"x 8" (4"x 6" wound contact surface). The wound contact side of the dressing is covered with scored siliconized release paper to permit aseptic application. The AllDress® Multi Layered Wound Dressing represents a modified version of the currently marketed AllDress® Multi Layered Wound Dressing (K945206) and is identical to the predicate device with respect to function and intended use. to the Comfeel® Plus Ulcer Dressing (K941263). The composition of the backing layer of the modified product has been changed to improve the wound barrier properties of the dressing. Biocompatibility of the modified device has been established by intracutaneous toxicity test (rabbit), systemic toxicity test (mice), muscle implantation test (rabbit), primary skin irritation test (rabbit), hemolysis test (In Vitro), cytotoxicity test (In Vitro), and delayed hypersensitivity test (guinea pig). In addition, bacterial penetration (strike-through) studies with S. aureus and P. aeruginosa and ASTM viral penetration test with фХ174 bacteriophage were conducted to demonstrate the effective performance of the dressing as a bacterial and viral barrier.