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510(k) Data Aggregation

    K Number
    K243457
    Device Name
    Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel
    Manufacturer
    Seriously Clean, Ltd
    Date Cleared
    2025-05-02

    (176 days)

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

    Seriously Clean, Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel is intended to be used for Over-The-Counter and Prescription Use. The Over-The-Counter use is intended for the following indications: - For use on minor skin irritations, minor cuts, exit sites, minor lacerations, minor abrasions and minor burns, including sunburns. - To moisten and lubricate absorbent wound dressings and moisten the wound bed. A moist wound and skin environment facilitates autolytic debridement. The Prescription Use Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel is indicated for the following uses: - Use with dermal irritation, sores, injuries and ulcers of dermal tissues. - Moistening and lubricating absorbent wound dressings and the wound bed and facilitate autolytic debridement of acute and chronic dermal lesions. - Management of partial or full thickness wounds such as 1st and 2nd degree burns, stage I – IV pressure ulcers, diabetic and stasis ulcers, abrasions and skin irritations, surgical wounds (donor and graft sites, incisions), trauma wounds, and various dermatoses including atopic dermatitis.
    Device Description
    The Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel is a hypochlorous acid hydrogel solution applied topically to skin and wound areas. The hydrogel dressing is supplied in various packaging configurations. The OTC hydrogel and the prescription use hydrogel contain hypochlorous acid, a known antimicrobial, which serves as a preservative to inhibit the growth of microorganisms in the hydrogel during shelf-life. The OTC and RX products are supplied non-sterile.
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