Search Results

SciVolutions Antibacterial Gentle Care Bandages are to be applied to the skin for topical application for minor cuts and scrapes.

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

This document is a 510(k) summary for a medical device (SciVolutions Antibacterial Gentle Care Bandages) and primarily focuses on establishing substantial equivalence to a predicate device. It does not contain information about the acceptance criteria and the detailed study that proves the device meets those criteria for the following reasons:

• Type of Device: This is a bandage with an antibacterial component. For such a device, the primary "performance" is often related to the antibacterial agent's efficacy and the bandage's physical properties (adhesion, breathability, comfort). However, the document provided is a 510(k) summary, which is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. It typically doesn't include detailed performance studies unless new claims are being made that go beyond those of the predicate device.
• Focus on Substantial Equivalence: The document explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device... and have determined that this device is substantially equivalent... to legally marketed predicate devices." This means the FDA has deemed it similar enough to an existing approved device that new, extensive clinical trials or performance studies specific to novel acceptance criteria are usually not required for market clearance.
• Lack of Specific Data: The document mentions the antibacterial component (Benzalkonium Chloride) and the physical characteristics of the backing and pad but does not present quantitative acceptance criteria (e.g., "bacterial reduction by X%") or the results of studies designed to meet such criteria. It states that the antibacterial pad is "identical" to the predicate, implying that its performance is already established.

Therefore, for this particular 510(k) summary, I cannot extract the specific information requested in your prompt regarding acceptance criteria and performance studies because it explicitly focuses on substantial equivalence rather than presenting new, detailed performance study outcomes with acceptance criteria.

Ask a specific question about this device