Wet Original® Personal Lubricant Receives FDA 510(k) Medical Device Clearance from Food and Drug Administration
By Business Wire News
By Business Wire News
Trigg Laboratories is proud to announce that its Wet Original® Personal Lubricant, which includes the Wet Flavored™ line, has been 510(k) cleared as a class II medical device by the U.S. Food and Drug Administration (FDA), meeting the appropriate provisions of the Federal Food, Drug and Cosmetics Act for good manufacturing practice, labeling and prohibitions against misbranding and adulteration.
“It’s a good thing the FDA has been cracking down on the lubricant industry, requiring every lubricant on the market to submit a 510(k) application to the FDA in order to legally be marketed. Consumers need to understand that Personal Lubricants are applied to mucous membranes (our most intimate areas) and are very easily absorbed into the body, so it’s important to make sure they are classified as Medical Devices by the FDA before purchasing and using them,” says Michael Trigg, founder and Chief Executive Officer of Trigg Laboratories, Inc.
Water based, Wet Original® is safe and effective as personal lubricant or vaginal moisturizer and known for its exceptional purity, consistency and comfort. It is compatible with latex, polyisoprene, and polyurethane condoms. Trigg Laboratories formulates all products in their FDA registered medical device manufacturing facility including compounding, filling and packaging all products in Valencia, California under strict cGMP guidelines.
“We will continue to meet the clinical standards that have made our products doctor-recommended and adult-preferred, and we are pleased to have the FDA regulating our ingredients and facility, to ensure we are meeting all safety guidelines so our customers can know with certainty that the WET lubricants they trust to go on and inside are being made to the highest possible standards. Trigg has many more applications in the works with the goal of having our entire line of lubricants 510(k) cleared by the end of 2016,” adds Trigg.
80-plus Wet® products including silicone and natural lubricants, arousal gels, and Japanese massage oils are available across the nation in select retail stores, in most adult boutiques or online at http://stayswetlonger.com.
For WET Lubricant
Dara Shlifka, 847-858-9933