Silverlon Silver Burn and Wound Care Products
                            
Silverlon Silver Burn and Wound Care Products
Advanced Silver Antimicrobial Burn,
Surgical and Wound Care Products
FDA Marketing Clearances

Listed below is a summary of the FDA marketing clearances for Silverlon® products:
Silverlon ® Calcium Alginate Dressing 510(k) # K053590
   October 11, 2006

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.

Main Wound Dressing Page
Silverlon® Wound Contact Dressing
Silverlon® Burn Contact Dressing
Silverlon® Burn Wrap Dressing
Silverlon® Acute Burn Glove
Silverlon® Negative Pressure Dressing 		510(k) # K023612
January 24, 2003

Description
The Silverlon® Wound Contact Dressing, Silverlon® Burn Contact Dressing, Silverlon® Burn Wrap, Silverlon® Acute Burn Glove, and Silverlon® Negative Pressure Dressing 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 and Wound Dressings are broad spectrum 7 day use antimicrobial barrier dressings.

Indications
The Silverlon® Wound Contact Dressing, Silverlon® Burn Contact Dressing, Silverlon® Burn Wrap, Silverlon® Acute Burn Glove, and Silverlon® Negative Pressure Dressing 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.

Over-The-Counter Indications:
First aid to help in minor abrasions, minor cuts, lacerations, scrapes, minor scalds and burns.

Main Wound Dressing Page
Main Burn Dressing Page
Silverlon® Island Dressing
Silverlon® Burn Pad Dressing
Silverlon® Wound Pad Dressing
Silverlon® Lifesaver™ IV/Catheter Wound Dressings
Silverlon® Adhesive Strip
510(k) # K023609
January 17, 2003

Description
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.

Main Wound Dressing Page
Main Burn Dressing Page
Silverlon® Wound Packing Strips 510(k) # K984210
   September 24, 1999
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

Main Wound Dressing Page
Silverlon®  Wound Contact Dressing 510(k) # K981299
   September 25, 1998
Description
Silverlon® Wound Contact Dressings are designed to intimately contact the wound as a primary dressing and permit the passage of fluids. The silver of the dressing provides effective protection against microbial contamination.

Indications
Silverlon® Wound Contact 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).

Main Wound Dressing Page
Silverlon FDA Clearances For a printer friendly version of this Silverlon®
FDA Marketing Clearance Page, please click here 		Silverlon FDA Clearances

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Contact Information
     
(Toll Free) Phone:
1-888-551-0188   
E-Mail Us at:
 contact@silverlon.com
 FAX #:
630-232-8005
Member - National Alliance of Wound Care


Member - Wound Care Education Institute

All of the Silverlon® Wound Care, Burn Care, and Surgical Products listed on this website are FDA Cleared.
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