Chesson Labs announced that it has received 510(k) market clearance from the US Food and Drug Administration (FDA) for NUVADERM, the Company’s liquid bandage product. The 510(k) clearance allows Chesson Labs to market and sell the product for use by healthcare professionals and directly to consumers.
The FDA has cleared claims on the product “to cover intact skin and minor cuts, scrapes, burns or irritations of the skin, to help keep them clean and dry and help protect them from infection.” The fast application, drying and coverage characteristics make NUVADERM well suited to meet the needs of individuals treating minor wounds. The product also has antimicrobial properties.
NUVADERM’s clearance is a significant milestone for Chesson Labs because it is their first medical
device submission to the FDA and first 510(k) clearance. The Company anticipates submission of
additional filings to the FDA as it continues to expand its product portfolio.
“NUVADERM’s clearance is a major milestone for Chesson Labs, but more importantly it is a product developed to improve wound care for individuals treating themselves as well as medical personnel who need a rapid response product to treat minor wounds,” said Scott Neuville, President and CEO of Chesson Labs.