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510(k) Data Aggregation

    K Number
    K151186
    Device Name
    Stay Fresh Hydrocolloid dressing
    Manufacturer
    SARASOTA MEDICAL PRODUCTS, INC.
    Date Cleared
    2015-11-27

    (207 days)

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

    SARASOTA MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Rx: Under the supervision of a healthcare professional, the Stay Fresh Hydrocolloid dressing is intended for use as a primary dressing for exuding wounds that acts as a barrier to bacterial penetration, for use on first and second degree burns, surgical wounds, pressure ulcers, dermal ulcers, as well as minor cuts, abrasions, lacerations. OTC: The Stay Fresh Hydrocolloid dressing acts as a barrier to bacterial penetration and is indicated for first aid to cover minor cuts, minor abrasions, and minor lacerations.
    Device Description
    Sarasota Medical Products hydrocolloid dressing adhesive formulations are composed of naturally occurring substances that turn into a gel when they come into contact with wound fluid. Superabsorbent particles are embedded in an inert polymer matrix that provides the desired level of cohesiveness required to prevent leaving any residue in the wound. The outer most layer of the dressing is covered by a polyurethane film that reinforces the dressing's barrier properties and helps to reduce friction on clothing, bedding, and opposing extremities. When placed over a wound, these dressings create a moist environment. This environment has been shown to help to facilitate the removal of debris and protect the wound against bacteria and other external contaminants. The Stay Fresh Hydrocolloid includes sequestered hydrogen peroxide (0.2 to 0.35% by weight). The sequestered hydrogen peroxide is an effective and safe antibacterial agent that protects the dressing. The role of antibacterial agents in wound dressings is: 1) to reduce the incidence of bacterial colonization within the dressing and 2) to provide a potential barrier to bacterial entry into the wound. The Stay Fresh Hydrocolloid is effective in controlling growth of bacteria commonly found to populate dressings. The outer thermoplastic layer is effective at providing a physical barrier to bacterial entry into the wound. The Stay Fresh Hydrocolloid dressing will be supplied sterile. Sterilization will be achieved by gamma radiation at 25 Kgy in accordance with ISO 11137 and ISO 14385.
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