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510(k) Data Aggregation
K Number
K955453Device Name
ACTICOAT SILVER COATED DRESSING
Manufacturer
WESTAIM TECHNOLOGIES, INC.
Date Cleared
1996-05-31
(184 days)
Product Code
KMF
Regulation Number
880.5090Why did this record match?
Applicant Name (Manufacturer) :
WESTAIM TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Acticoat™ silver coated dressing is intended for use as an effective barrier to bacterial penetration and as a method to reduce infection of partial and full thickness wounds.
Device Description
Acticoat™ silver coated dressing is a 3-ply gauze wound dressing consisting of an absorbent rayon/polyester core and an upper and lower layer of silver coated high density polyethylene mesh designed to be a barrier against microbial infections of a wound. The silver in the coating is an alloy of silver and oxygen. The coating is highly porous, and the film has enhanced solubility in water-based fluids. Additionally, the performance characteristics of the Acticoat™ silver coated dressing are similar to those found in untreated gauze-based dressings in the areas of absorptivity and moisture content, abrasion resistance and adhesion, and tensile strength.
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