VALENCIA, Calif. — Trigg Laboratories has announced that Wet Platinum Premium personal lubricant has received Section 510(k) medical device approval from the U.S. Food and Drug Administration, which allows this silicone, latex-friendly product “to be marketed in interstate commerce as substantially similar to other legally marketed predicate products.”
“Recent research on lubricant use and potential HIV infection found Wet Platinum to be one of the two safest lubricants tested, in terms of the toxicity,” the company said, adding that Wet Platinum was developed, tested and is manufactured “to comply with stringent FDA Medical Device regulations” in Trigg Laboratories’ state-of-the-art facilities.
According to the company, the FDA approval means that Wet Platinum meets the appropriate provisions of the Federal Food, Drug and Cosmetics Act for good manufacturing practice, labeling and prohibitions against misbranding and adulteration.
"Since our company was founded in 1989, we have advocated safe sex practices and are committed to providing adults with top-quality, fully effective lubricant products,” said Michael Trigg, founder and CEO of Trigg Laboratories. “This new FDA approval of our 510(k) submission will enable us to continue expanding our national marketing, while assuring retailers and consumers that Wet Platinum, like all our Wet products, will continue to meet the clinical standards that have made it doctor-recommended and adult-preferred.”
Wet Products are widely available at many specialty and mass retailers including Walgreens, CVS, Rite Aid, HEB, Shoppers Drug Mart and Target, as well as in novelty and boutique stores.
