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

Wet Platinum

Wet® Platinum® Premium Personal Lubricant has received 510(k) medical device clearance from the U.S. Food and Drug Administration, which allows this 100% silicone, condom compatible product to be marketed in interstate commerce as a legal medical device controlled by the FDA. The FDA clearance 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.

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. Manufactured by Trigg Laboratories, one of the world’s best-selling makers of personal lubricants and intimacy products, Wet® Platinum® has been developed, tested and manufactured to comply with stringent FDA Medical Device regulations, in state-of-the-art facilities, for exceptional purity, consistency and comfort. Wet® Platinum® is guaranteed never sticky and is the longest lasting formula in the Wet line of products. It never dries and leaves the skin feeling soft and moisturized. Because it doesn’t break down in water, it can be used in the bath, shower, or spa or for full body massages and skin conditioning. The silky smooth 100% silicone formula is latex friendly and doctor recommended.

“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 Chief Executive Officer of Trigg Laboratories, Inc., makers of a full line of Wet® Personal Lubricants. “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. Developed, formulated and packaged at the 52,000 square-foot, state-of-the-art Trigg Laboratories facility in Valencia, California, each of the 80-plus Wet® products are manufactured and tested in compliance with the FDA’s strict Medical Device Quality System Regulations (QSR) and current Good Manufacturing Practices (cGMP), and include a large variety of personal and flavored lubricants, flavored heating massage lotions and aromatherapy heating massage oils.

Article by heraldonline.com