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Silverlon™ Direct Pressure (DP) Wound Closure Strips are absorbent antimicrobial barrier dressings. The Over-The-Counter (OTC) indications: Local management of superficial wounds and skin tears and minor lacerations. The Prescription Professional indications: Primary or secondary closure following surgery, supplementary-support to sutures, staples or sealants, wound support following suture removal, and wound sites where suturing would aggravate bleeding.

Silverlon™ DP Wound Closure Strips are designed to provide a balanced relief of tensions at the wound edges by exerting a compressive and downward force on the wound surface through the antimicrobial barrier multilaminate composite portion of the strip. Without impairment of microcirculation, the elastasticity of the non latex elastic component provides a stabilizing force to the wound edge reapproximation. The Silverlon™ component provides effective protection of the dressing against microbial contamination. The dressing maintains a moist wound environment which promotes wound healing. The design of the elastic component allows for the wound edges to be pulled together while minimizing the irritation, blistering and skin shearing associated with mechanical trauma. As the patient goes through the activities of daily living, the antimicrobial barrier composite laminate pad experiences minimal motion and therefore minimal disruption of the wound margins. The pattern of the elastic design of the DP portion of the closure strip provides the minimal motion and intimate contact between the antimicrobial barrier laminate and the wound margins as the edema subsides. The design of the relief holes in the elastic non latex elastic component allow: (1) minimum movement of the laminate and the wound edges as the surrounding skin moves; and (2) the physician to vary the compression on the wound surface after the dressing is applied by cutting bands. Silverlon™ DP Wound Closure Strips are multi-layer, sterile, elastic, antimicrobial barrier absorbent composite wound closure strips. The dressings are composed of five distinct layers outlined in Figure 1 below: Layer 1 is a non-adherent wound contact layer that consists of 1 or 4 layers of 0 continuous nylon fiber substrate with a metallic silver surface (Silverlon™). Layer 1, Layer 2, Layer 3, and Layer 4 are sewn together with silver nylon thread that is plated in an identical fashion to the silver nylon utilized to make the Silverlon™ fabric. The silver coating is a uniform 1-micron thick layer that completely covers the nylon. Layer 2 is Delnet P530N Layer 3 is a needle-punched non-woven 8-ounce or 4-ounce rayon wed that absorbs drainage from the wound site Layer 4 is polyurethane film that keeps external contaminants out and maintains a moist wound healing environment. (Note: Layers 2, 3,and 4 are manufactured as a laminate by AET) Layer 5 is a composite laminate of non-woven polyester fabric (5.2, Figure 1) . coated with a skin contact pressure sensitive acrylic adhesive (5.4, Figure 1) backed with a one sided poly coated lay flat release liner and non latex elastic. The pressure sensitive acrylic adhesive H-566, is a hypoallergenic adhesive that meets USP Class 6 standard and satisfies tripartite guidelines for skin contact devices. The non-woven polyester tape is interrupted by a section of elastomeric non latex (5.1. Figure 1). Holes are punched out in the non latex elastic (5.3, Figure 1) to allow adjustability of the elastic component of the Silverlon™ DP Wound Closure Strip.

This device may not be labeled for use on third degree burns. This device may not be labeled as having any accelerating effect on the rate of wound healing or epithelization. This device may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin. This device may not be labeled as a treatment or a cure for any type of wound.

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For over-the-counter use, Silverlon® Wound Contact Dressing may be used for: First aid to help in minor abrasions, minor cuts, lacerations, scrapes, minor scalds and burns. Under the supervision of a health care professional, Silverlon® Wound Contact Dressing may be used for the management of: Silverlon® Wound Contact Dressings provide an effective barrier to bacterial penetration and are intended for local management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, and Stage I-IV dermal ulcers (vascular, venous, pressure, and diabetic).

Silverlon® Contact Wound Dressings are made of flexible, elastomeric, sterile, silver plated fabric consisting of a knitted continuous nylon fiber substrate with a metallic silver surface containing approximately one percent silver oxide. The coating of silver is circumferential between 0.8 and 1.0 um thick. Silverlon® Contact Wound Dressings are designed to intimately contact the wound as a primary dressing and permit the passage of fluids. The silver provides effective protection of the dressing against microbial contamination. The nylon fabric permits the passage of oxygen and fluids to and from the wound. The surface of the nylon fibers in Silverlon® Wound Contact Dressings consists of a thin layer of metallic silver containing approximately one percent silver oxide that provides effective protection of the dressing against microbial contamination.

Professional Indications: Indicated for vascular access, central, arterial and venous IV sites, IM injection sites, abrasions, lacerations, partial thickness burns, wound drain sites and surgical incisions. Over-The-Counter Indications: First aid to help in minor cuts, scrapes, abrasions and burns.

Silver nylon strips are multi-layer, sterile, non-adherent, absorbent composite dressings with an attached adhesive tape or pad. The dressings are composed of three distinct layers: Layer 1 is a polymeric silver coated fabric circumferential covered with a uniform layer of metallic silver. Layer 2 is a needle-punched non-woven rayon web that absorbs drainage from the wound site. Layer 3 is a latex free skin adhesive and tape.

Silverlon™ Wound Packing Strips are sterile, non-adherent, silver wound dressings. The Prescription Professional indications: Control of local wound bleeding and nasal hemorrhage, to encourage draining by wicking fluids from a body cavity, infected area, or abscess, and to help remove necrotic tissue from ulcers or other infected wounds when used as a "wet-to-dry" packing.

Silverlon® Wound Packing Strips are made of flexible, sterile, r non-adherent fabric of a knitted continuous nylon fiber substrate with a metallic silver surface containing approximately 1% silver oxide. Silverlon® Wound Packing Strips are designed to intimately contact the wound as a primary dressing and permit the passage of fluids. The silver provides effective protection of the dressing against microbial contamination. The nylon fabric permits the passage of oxygen and fluids to and from the wound. The surface of the nylon fibers in Silverlon® Wound Packing Strips consists of a thin layer of metallic silver containing approximately 1% silver oxide that provides effective protection of the dressing against microbial contamination.

Silverlon™ Island Wound Dressings are multi-layer, sterile, non-adherent, absorbent, composite, antimicrobial barrier wound dressings indicated for local management of superficial wounds, minor burns, and abrasions and lacerations. A health care professional may be consulted prior to the first use of this product to determine whether these conditions exist. Silverlon™ Island Wound Dressings may also be used under the care of a health care professional for wounds such as vascular access or peripheral IV sites, orthopaedic external pin sites, wound drain sites, surgical wounds (donor and graft sites, incisions), and partial to full thickness dermal ulcers (pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers). Topical application of Silverlon™ Island Wound Dressings protects the wound area and the open weave of the silver-nylon fabric wound contact layer permits passage of wound fluid through the product to be absorbed by an overlying absorbent material. The silver provides effective protection of the dressing against microbial contamination. The Over-The-Counter indications: Local management of superficial wounds, minor burns, abrasions and lacerations. The Prescription Professional indications: Wounds such as vascular access or peripheral IV sites, orthopaedic external pin sites, wound drain sites, surgical wounds (donor and graft sites, incisions), and partial to full thickness dermal ulcers (Stage I-IV pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers).

Silverlon™ Island Wound Dressings are multi-layer, sterile, non-adherent, absorbent composite dressings with an attached adhesive tape or pad. The dressings are composed of five distinct lavers: - Layer 1 is a non-adherent wound contact layer that consists of 1 or 4 layers of knitted continuous nylon fiber substrate with a metallic silver surface (Silverlon™). The layers of Silverlon™ are sewn together with silver nylon thread that is plated in an identical fashion to the silver nylon utilized to make the Silverlon™ knitted fabric. The silver coating is a uniform 1-micron thick layer that completely covers the nylon. - Layer 2 is Delnet P530N - Layer 3 is a needle punched non-woven 8-ounce rayon web that absorbs drainage from the wound site. - Layer 4 is polyurethane film that keeps external contaminants out and maintains a moist wound healing environment. (Note: Layers 2, 3, and 4 are manufactured as a laminate by AET). - Layer 5 is a non-woven polvester fabric coated with a skin contact pressure sensitive acrylic adhesive backed with a one sided poly coated lay flat release liner. The pressure sensitive acrylic adhesive is H-566 a hypoallergenic adhesive that meets USP Class 6 standard and satisfies tripartite guidelines for skin contact devices. The Silverlon Island Pad does not have the tape layer.

Silverlon™ Contact Wound Dressings are sterile, non-adherent dressings intended for local management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and Stage I-IV dermal ulcers (vascular, venous, pressure, and diabetic).

Silverlon™ Contact Wound Dressings are designed to intimately contact the wound as a primary dressing and permit the passage of fluids. The silver provides effective protection of the dressing against microbial contamination. The nylon fabric permits the passage of oxygen and fluids to and from the wound. The surface of the nylon fibers in Silverlon™ Contact Wound Dressings consists of a thin layer of metallic silver containing approximately 1% silver oxide that provides effective protection of the dressing against microbial contamination. Silverlon™ Contact Wound Dressings are made of flexible, sterile, non-adherent fabric consisting of 1 or 4 layers of a knitted continuous nylon fiber substrate with a metallic silver surface containing approximately 1% silver oxide.