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510(k) Data Aggregation

    K Number
    K122817
    Device Name
    SILVERLON ISLAND WOUND DRESSING
    Manufacturer
    ARGENTUM MEDICAL, LLC.
    Date Cleared
    2014-05-01

    (594 days)

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

    ARGENTUM MEDICAL, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Silverlon® Island Wound Dressings is a multi-layer, sterile, non-adherent, antimicrobial barrier wound dressing. The Over-The-Counter Indications: Local management of superficial wounds, minor burns, abrasions and lacerations. Under the supervision of a healthcare professional Silverlon Island Wound Dressings are intended for up to 7 day use for wounds such as vascular access or peripheral IV sites, orthopedic external pin sites, surgical wounds (donor and graft sites, incisions), and partial to fill thickness dermal ulcers (stage I-IV pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers). Silverlon® Island Wound Dressing is indicated for the management of infected wounds', as the silver in the dressing provides an antimicrobial barrier that may be helpful in managing these wounds. In addition, the moist wound healing environment and control of wound bacteria within the Silverlon® Island Wound Dressing may help reduce the risk of wound infection and support the body's healing process. Silverlon® Island Wound Dressing may be used for the management of painful wounds' Silverlor® Island Wound Dressing's non-adherent wound contact layer reduces pain during dressing changes and evaporation of moisture in the dressing may sooth the wound. 1Clarified/New Indication, not previously included in this format under K984208.
    Device Description
    Silverlon® Island Wound Dressing is a self-adhesive, elastomeric wound dressing composed of 5 distinct layers (in innermost to outermost order): · Layer 1 is a non-adherent wound contact layer that consists of a single layer of knitted continuous nylon fiber coated with metallic silver at the rate of 5.05 mg/cm (50.5 g/m²); the silver surface coating is approximately 0.8 - 1.0 um thick and contains approximately 1% silver oxide). - · Layer 2 is a polyethylene film used to bond the nylon substrate to the pad layer described below; - · Laver 3 is a laminate pad with an absorptive capacity of 65 oz/yd2 to absorb wound exudate; · Layer 4 is an apertured high density polyethylene film that bonds the pad to the outer polyester fabric described below; and, · layer 5 is a non-woven, medical grade polyester fabric coated on the skin-contacting side with a self-curing acrylic, pressure-sensitive, medical grade adhesive covered with a silicone-coated (one side) paper liner. Laver 1 delivers antimicrobial silver ions in the dressing when activated by moisture. The silver ions in the dressing kill wound bacteria held in the dressing and provides an antimicrobial barrier to protect the wound bed. This dressing absorbs high amounts of wound fluid and the dressing intimately conforms to the wound surface.
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    K Number
    K053590
    Device Name
    SILVERLON CA (CALCIUM ALGINATE)
    Manufacturer
    ARGENTUM MEDICAL, LLC.
    Date Cleared
    2006-10-06

    (287 days)

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

    ARGENTUM MEDICAL, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Silverlon™ CA Advanced Antimicrobial Alginate Dressing is an effective barrier to microbial penetration for moderate to heavy exudating partial and fullthickness wounds, including pressure ulcers, venous ulcers, diabetic ulcers, donor and graft sites, traumatic and surgical wounds and 1st and 2nd degree burns. Silverlon™ CA Advanced Antimicrobial Dressing is indicated for external use only.
    Device Description
    Silverlon™ CA Advanced Antimicrobial Alginate Dressing, is a sterile, non-woven pad composed of a calcium (and sodium) alginate and a silver nylon contact layer. The dressing is available in various sizes ( 2" x 2", 4.2", 4.25" x 4.25", 4" x 8", 8" x 12", and a %" x 12" rope) and packaged in Tyvek pouches. The release of silver ions provides an antimicrobial barrier, which protects the dressing from microbial colonization. The dressing absorbs exudates, maintains a moist wound environment and allows for intact removal.
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