Listed below is a summary of the FDA marketing clearances for Silverlon® products:
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Silverlon® Wound Contact Dressing
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510(k) # K981 299
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September 25, 1998
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Description
Dressings designed to be placed directly on the wound surface to reduce
the potential disruption of the healing tissue during routine dressing
changes.
Indications
• for post surgical wounds, skin ulcers, partial thickness burns,
newly applied skin grafts and flaps
• for pressure sores, dermal ulcers, vascular ulcers, and diabetic
ulcers
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Silverlon® Wound Packing Strips
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510(k) # K984210
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September 24, 1999
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Description
This dressing is a sterile, non adherent, antimicrobial barrier dressing
that can be packed into any type of infectious open wound that cannot
be closed primarily.
Indications
• to control local bleeding and nasal hemorrhage
• to encourage draining by wicking fluids from a body cavity, infected
area, or abscess
• to help remove necrotic tissue from ulcers or other infected
wounds when used as a “wet to dry” packing
• local management of lacerations in the Over The Counter Market
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Silverlon® Island Dressing, Wound Pad Dressing, & Adhesive Strip
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510(k) # K023609
January 17, 2003
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Description
Silverlon® Island Dressing, Wound Pad Dressing, and Adhesive Strips are multi-layer, sterile, non-adherent antimicrobial barrier wound dressings designed to be primary dressings in intimate contact with the wound. They provide a microbial barrier, permit the passage of wound fluids, are absorbent, and provide effective protection of the dressing against microbial contamination.
Indications
Professional Indications:
Indicated for vascular access, central, arterial and venous IV sites, IV 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.
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Silverlon® Calcium Alginate Dressing
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510(k) # K053590
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October 11, 2006
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Description
Silverlon™ CA Advanced Antimicrobial Alginate Dressing, is a sterile, non-woven pad composed of a High M (manuronic acid) alginate and a silver nylon contact layer. The silver ions provide an antimicrobial barrier which protects the dressing from bacterial contamination. The dressing absorbs exudates, maintains a moist wound environment and allows for intact removal.
Indications
Silverlon™ CA Advanced Antimicrobial Alginate Dressing is an effective barrier to microbial penetration for moderate to heavy exudating partial and full-thickness 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.
Silverlon® Burn Contact Dressing
Silverlon® Burn Wrap Dressing
Silverlon® Acute Burn Glove
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510(k) # K023612
January 24, 2003
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Description
The Silverlon® Burn Contact Dressing, Silverlon® Burn Wrap, and Silverlon® Acute Burn Glove are designed to intimately contact the burn/wound as a primary dressing and permit the passage of fluids. The silver provides effective protection of the dressing against microbial contamination. These Burn Dressings are broad spectrum 7 day use antimicrobial barrier dressings.
Indications
The Silverlon® Burn Contact Dressing, Silverlon® Burn Wrap, and Silverlon® Acute Burn Glove are indicated for the local management of 1st and 2nd Degree Burns, Partial and Full-thickness Burns, Donor and Graft Sites, Acute Wounds, Lacerations, Abrasions, Traumatic Wounds, Surgical Wounds, Dehisced Wounds, Stage I-IV Dermal Ulcers, Pressure Ulcers, Diabetic Ulcers, and Venous Ulcers.
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