Wet Original® Personal Lubricant Receives FDA 510(k) Medical Device Clearance from Food and Drug Administration

VALENCIA, Calif.–(BUSINESS WIRE)–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 https://stayswetlonger.com.