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K Number
K020318
Device Name
SCIVOLUTIONS VARIOUS ANTIBACTERIAL BANDAGES
Manufacturer
SCIVOLUTIONS, INC
Date Cleared
2003-02-03

(369 days)

Product Code
FRO,MXE
Regulation Number
N/A
Type
Traditional
Panel
SU
Reference & Predicate Devices
K992817
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Antibacterial Adhesive Bandages are to be applied to the skin for topical application. The bandages help provide an antibacterial barrier for minor cuts and scrapes.

Device Description

Antibacterial adhesive bandages are similar to many pre-amendment and already cleared products with benzalkonium chloride. They are provided in various sizes in a box for over the counter purchase. The benzalkonium chloride concentration is 1%.

AI/ML Overview

I am sorry, but the provided text does not contain the information required to answer your request. The documents are FDA 510(k) letters and a 510(k) summary for "SciVolutions Antibacterial Bandages." They primarily discuss regulatory classifications, indications for use, and a comparison to a predicate device.

The documents do not include:

  • A table of acceptance criteria or reported device performance metrics.
  • Details about a study (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance).
  • Information about training sets.

Therefore, I cannot fulfill your request based on the provided input.

N/A