Continued Expansion of gel-e's Consumer Products Label
Thursday, October 31, 2019
Unique product platform combines antibacterial capabilities within a high-performance hemostat
Gaithersburg, Md., October 31, 2019 - gel-e Inc., announces Breakthrough Status Designation from the U.S. Food and Drug Administration (FDA) for its first internal-use flowable device.
The Company is developing a line of advanced hemostatic and wound treatment products that address unmet needs from the battlefield to the backyard. Following the FDA's recent designation of our LifeFoam™ military product as a "Breakthrough" device and building on previous clearances for topical use of its platform technology (see http://www.gel-e.co/news.html), the Company is now expanding its' Over-The-Counter (OTC) consumer products label. The Company's cleared consumer product's label has been strategically developed starting with hemostatic and wound treatment claims (K172010 & K180152), now expanded to include the creation of antibacterial environments, non-sterile manufacture, longer and more durable shelf- & use-life, all provided in "non-irritating, convenient, and easy to apply" products (K182811 & K192667). These regulatory clearances, provide a foundation for bandage and gel-based products that can be used to manage acute bleeding, and although these products are not intended to treat active infections, they can deliver an effective antimicrobial barrier designed to prevent bacterial infection in a moist, clean healing environment.
Read the full release from gel-e.