Wet Lubricants gain 510(k) clearance as a class II medical device

VALENCIA, Calif. - Trigg Laboratories on Monday announced 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.

 

“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," stated Michael Trigg, CEO Trigg Laboratories. "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.” 

 

Water-based, Wet Original is safe and effective as personal lubricant or vaginal moisturizer and is compatible with latex, polyisoprene and polyurethane condoms. 

 

“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 added. "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."