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510(k) Data Aggregation

    K Number
    K153678
    Device Name
    PermeaDerm B, PermeaDerm CW, and PermeaDerm Glove
    Manufacturer
    Date Cleared
    2016-08-08

    (231 days)

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

    PERMEADERM, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    PermeaDerm B, CW and Glove are intended for use as wound coverings and to provide a moist wound healing environment on cleanly debrided wounds after hemostasis has been established. PermeaDerm B is indicated for partial thickness burn wounds, donor sites and coverage of meshed autograff. PermeaDerm CW is indicated for partial thickness wounds, pressure sores, diabetic ulcers, chronic vascular ulcers, surgical wounds (donor sites/grafts, post-Moh's, post-laser surgery, podiatric, wound dehiscence, trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) and draining wounds. PermeaDerm Glove is indicated for debrided partial thickness hand burns.
    Device Description
    PermeaDerm B, PermeaDerm CW and PermeaDerm Glove are identical in chemical composition and 3D structure. They are all composed of a monofilament nylon knitted fabric (virgin Indachi Nylon Monofilament Yarn 15/1), bonded to a thin slitted silicone membrane (Unrestricted Medical Grade Silicone, Applied Silicone, Dimethyl-Silicone-Elastomer P/N 40000). The nylon side of this dressing is coated with a mixture of hypoallergenic porcine gelatin (Gelita MedellaPro®) and a pure fraction of Aloe vera (Aloecorp Inc. Immuno-10®). The physical differences in the two configurations (PermeaDerm B versus PermeaDerm CW and PermeaDerm Glove) are in the number and orientations of slits per unit area. PermeaDerm B contains 2280 parallel slits (0.25" long) per square foot. PermeaDerm CW contains 4,464 slits (0.180" long) per square foot, and the rows of slits are parallel or perpendicular in orientation. PermeaDerm Glove has identical and physical properties of PermeaDerm CW, except it is sewn into a glove configuration. The slit configuration creates pores when the dressing is stretched. All configurations provide a moist wound healing environment with a slitted silicone/nylon membrane coated with gelatin and aloe vera extract. The wound dressings are primary dressings, to be used with secondary absorbent cover dressings.
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