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510(k) Data Aggregation
K Number
K082910Device Name
CVS SILVER BANDAGES, WALGREENS SILVER BANDAGES, XYZ SILVER BANDAGES
Manufacturer
Date Cleared
2009-06-17
(260 days)
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
ASO LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Under the supervision of a healthcare professional, Silver Bandages are indicated for the management of pressure ulcers diabetic foot ulcers, as well as minor cuts, scrapes, abrasions, lacerations, and burns.
The Bandages are indicated for first aid to cover minor cuts, scrapes, abrasions, lacerations and burns.
Device Description
There will be two primary models covered under this submission, the Silver Bandage which will be available by prescription only and the Bandage which will be available for over-the-counter use.
Silver Bandage is an adhesive bandage that includes silver in the wound pad. The bandage covers the wound area. The Silver Bandage may be used under supervision of a healthcare professional. In Vitro testing showed that silver in the pad reduced bacterial growth by over 99% (S. aureus. S. aureus(MRSA), E. coli, E. hirae and P. aeruginosa) for 24 hours contact time.
The Bandage is an adhesive bandage which may be purchased for over-the-counter use as a first aid. The device consists of a hydrophyillic pad stock with sufficient absorbency to absorb normal quantities of blood or other wound exudates typical of minor abrasions or lacerations, supplied on a flexible, non-absorbent backing coated with a pressure sensitive adhesive capable of adhering the device to human skin
The both bandages have a traditional bandage design consisting of an adhesive coated backing, wound pad that contains silver, paper release tabs and protected by a cohesive coated paper wrapper that serves as the sterile barrier.
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