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510(k) Data Aggregation

    K Number
    K220673
    Device Name
    Sterile Silver Alginate Wound Dressing
    Date Cleared
    2023-03-16

    (374 days)

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

    Qingdao Bright Moon Biomedical Materials Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Prescription Use: Sterile Silver Alginate Wound Dressing (Rx only) is indicated for the management of moderate to heavily exuding partial to full thickness wounds, including, postoperative wounds, leg ulcers, pressure ulcers, diabetic ulcers, graft and donor sites. OTC: Sterile Silver Alginate Wound Dressing (OTC) is first aid to help in minor cuts, minor lacerations, minor scrapes, minor scalds and minor burns.
    Device Description
    Sterile Silver Alginate Wound Dressing is a sterile, single-use dressing composed of calcium alginate and silver antibacterial agent. This highly absorbent dressing vertically absorbs wound exudate and release silver ions within the dressing in the presence of wound fluid to help reduce bacteria within the dressing. As wound exudate is absorbed, the alginate forms a gel, which assists in maintaining a moist environment and allows intact removal. Based on in-vitro testing, the silver in the dressing inhibits bacterial growth in the dressing for up to seven days. No clinical benefit has been demonstrated regarding the antibacterial effectiveness of the silver component.
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