(58 days)
Non-woven dressing with pre-cut fenestration for use around tracheostomy or IV tubes to absorb exudate and absorb fluids.
Sterile Drain Sponges
The provided document is a 510(k) clearance letter from the FDA for a device described as "Sterile Drain Sponges." This type of document does not contain any information regarding acceptance criteria, device performance studies, or AI/software analysis.
The letter confirms that the device is substantially equivalent to a legally marketed predicate device, falling under the "Unclassified" regulatory class. It outlines general regulatory requirements but makes no mention of performance metrics or specific studies, as these types of devices (drain sponges) are typically cleared based on material composition and intended use rather than clinical performance studies.
Therefore, I cannot provide the requested information based on the input document.
§ 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.