(141 days)
3M™ Tegaderm™ CHG Dressings (Chlorhexidine Gluconate Securement Dressing), can be used to cover and protect catheter sites and to secure devices to skin. Common applications include IV catheters, other intravascular catheter and percutaneous devices.
3M™ Tegaderm™ ™ CHG Dressing, Chlorhexidine Gluconate Securement Dressing, is used to cover and protect catheter sites and to secure devices to skin. Available in a variety of shapes and sizes to meet the needs of the caregiver.
Tegaderm™ CHG Dressing consists of a transparent adhesive dressing and an integrated pad containing Chlorhexidine Gluconate (CHG), a well-known antiseptic agent with broad-spectrum antimicrobial and antifungal activity. The dressing is a barrier to liquid (waterproof), bacteria and yeast, and protects the IV site from outside contamination. The pad absorbs up to eight times its weight in fluid. In vitro testing (log reduction, barrier, and zone of inhibition) demonstrates that the Tegaderm™ CHG dressing has an antimicrobial effect against, and is a barrier to, the passage of a variety of gram-positive and gram-negative bacteria and yeast in the dressing.
Teqaderm™ CHG Dressing is transparent, allowing continual site observation, and is breathable, allowing good moisture vapor exchange.
This document is a 510(k) Premarket Notification for a medical device (3M™ Tegaderm™ CHG Dressing). It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement that would be relevant to answering your specific questions regarding a device's performance against acceptance criteria.
The document essentially states that the FDA reviewed the application and determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It does not provide the detailed study results you are asking for.
Therefore, I cannot populate the table or answer the specific questions you posed based on the provided text. The document is primarily a regulatory approval notice, not a clinical study report.
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