(178 days)
GluSeal™ liquid adhesive bandage is intended to cover minor cuts, scrapes, burns, and minor irritations of the skin and help protect them from infection.
GluSeal™ is monomeric 2 octyl cyanoacrylate. This compound, which exists in monomeric form in the plastic containers, polymerizes extremely rapidly in the presence of anions, especially of hydroxyl ions (in the presence of water).
GluSeal™ will be packaged in three different ways ranging from a multiuse bottle containing 5 ml cyanoacrylate; a multiuse vial containing 1 ml cyanoacrylate, and a kit containing 12 x 0.2 ml disposable applicators. Each of the multiuse kits will contain application pipettes and administration dishes or administration trays.
The provided text is a 510(k) summary for the medical device GluSeal™, a liquid adhesive bandage. It details the device's characteristics and its substantial equivalence to a predicate device, but it does not contain any information regarding specific acceptance criteria, study data, or clinical trials to prove device performance.
Therefore, I cannot provide the requested information in the format you described. The document primarily focuses on regulatory approval based on equivalence to a previously cleared device (CLOSURE Medical Corporation's LIQUIDERM™) rather than a de novo study with acceptance criteria and performance metrics.
Specifically, the document states:
- "The intended use and chemical structure of the GluStitch, Inc.'s GluSeal™ and CLOSURE Medical Corporation's LIQUIDDERM™ are equivalent." This is the core argument for its clearance, implying that since the predicate device was deemed safe and effective for its intended use, a device with equivalent characteristics will also be safe and effective.
To provide the information you asked for, a different type of document, such as a clinical study report or a detailed test report, would be necessary.
§ 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.