(36 days)
To absorb exudate and to create and maintain a moist environment for partial and full thickness wounds including pressure ulcers, stage I-V; stasis ulers; dermal wounds; 1ª and 2ª degree burns; cuts, abrasions, and other imitations of the skin.
DermaMend™ Hydrogel Gauze Dressing
This document is a 510(k) clearance letter for the DermaMend™ Hydrogel Gauze Dressing. It indicates that the device is substantially equivalent to legally marketed predicate devices.
However, the document does not contain any information about acceptance criteria or a study proving the device meets those criteria, as typically found in clinical trial reports or performance testing summaries.
Instead, it specifies limitations on the device's labeling and claims based on its classification and the 510(k) review process. These limitations effectively act as "negative acceptance criteria" for marketing claims.
As a result, I cannot provide the requested information from the provided text. The tables and other requested details regarding acceptance criteria, study design, sample sizes, ground truth, experts, and comparative effectiveness are not present in this regulatory clearance letter.
§ 880.5090 Liquid bandage.
(a)
Identification. A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.