The Silverlon® Advantage
Characteristic
Silverlon® Dressings
Standard Dressings
Antibacterial/
Antifungal
Antibacterial & Antifungal to all species
Not Antimicrobial
Cost Effective
Fewer dressing changes required.
Reduced material & labor costs
Traditional dressing change protocol
Nonresistant
No reports of any bacterial or fungal resistance.
Not Antimicrobial
Analgesic
Reduced bacterial contamination reduces inflammatory response arid related
pain.
No comparable mechanism
Hypoallergenic
Hypoallergenic, non- toxic and optimizes healing without the use of harsh
chemicals.
No comparable characteristic
FDA Approval
The below noted Silverlon® wound dressings have been cleared by the FDA and
premarket notifications have been issued.
Device Name
FDA 510(k)
FDA Approval Date
Silverlon® Contact Wound Dressing
K# 981299
25 September 1998
Silverlon® Island Wound Dressing and Silverlon Island Pad
K# 984208
22 February 1999
Silverlon® Adhesive Strip
K# 984205
22 February 1999
Silverlon® Direct Pressure® Wound Dressing
K# 984208
22 February 1999
Silverlon® Direct Pressure® Wound Closure Strip
K# 984204
22 February 1999
Silverlon® Wound Packing Strips
K# 984210
24 September 1999
FDA Approved Indications for Silverlon® Wound Care Products
Argentum plans to launch six primary Silverlon® wound care products
during the third and forth quarters of 2000. Each product is intended for a
particular use, although more than one product can be used for a single
application, depending on the physician's choice, the size of the wound and
other factors.
