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510(k) Data Aggregation
K Number
K032983Device Name
SENSITIVE SKIN ANTIBACTERIAL BANDAGES
Manufacturer
SCIVOLUTION, INC.
Date Cleared
2004-06-01
(251 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
SCIVOLUTION, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SciVolutions Antibacterial Gentle Care Bandages are to be applied to the skin for topical application for minor cuts and scrapes.
Device Description
The Antibacterial Gentle Care Bandages uses the identical BZC antibacterial pad as on The Antibactional Gentre Garden ander K020318. Only the backing (non-woven) our providually clours providing a higher water vapor permeability and soft feel.
Antibacterial Gentle Care Bandages
Non-woven skin color treated hydrophobic backing (Latex Free)
Central pad: High absorption capacity, covered with an anti adherent polyethylene veil, Ochtral pad. Figh abound, impregnated with 1% benzalkonium chloride solution.
Encased in Latex Free Kraft Paper Cold Sealed to make a envelope wrapper
Sizes: .75" x 3" / 1" x 3"
Uses: Gentle Care 25
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