Simply Slick Personal Lubricant receives FDA 510(k) Clearance

By on October 28, 2014

JANESVILLE, WI. – Simply Slick™ Personal Lubricant has received Section 510(k) medical device approval from the U.S. Food and Drug Administration, which allows this organic, oil-based, and condom safe (Latex, Polyisoprene, and Polyurethane) product to be marketed in interstate commerce as substantially similar to other legally marketed predicate products. The FDA clearance means that Simply Slick™ has passed all laboratory tests to ensure the product and ingredients are safe and it 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 dangers by the World Health Organization and other international entities have triggered a new round of FDA reviews for all personal lubricants being sold in the United States. By December 31, 2015, the FDA will review 100 percent of device types subject to a PMA that have been on the market to determine whether or not to shift some premarket data requirements to the postmarket setting or to pursue down classification, and communicate those decisions to the public. Simply Slick™ Personal Lubricant is cleared under the new test protocols and procedures set forth by the FDA. In Cytotoxity tests performed on Simply Slick™, Simply Slick™ scored a 0 out of 5; 5 being very toxic to cells and 0 being completely non-toxic.

Manufactured by Simply Solutions, one of the world’s leading makers of organic personal lubricants and herbal remedies, Simply Slick™ 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 quality. Simply Slick is an oil-based lubricant that provides long-lasting lubricity while remaining compatible with latex and non-latex condoms. It never dries and leaves the skin feeling soft and moisturized. Because our oil-based formula breaks down with water, it will not stain sheets or clothing. The silky smooth oil-based formula is latex friendly and doctor recommended.

“Since our company was founded, we have advocated safe and healthy sex practices while applying real science to organic compounds.” said John Goepfert, Founder and Chief Executive Officer of Simply Solutions LLC., makers of Simply Slick™ Personal Lubricant. “This new FDA clearance of our 510(k) submission will enable us to expand our national marketing, while assuring retailers and consumers that Simply Slick™, like all of our products, will continue to meet the clinical standards that have cleared it for sale by the FDA.”

Simply Slick™ is available at many specialty and mass retailers as well as in novelty and boutique stores. Our products are manufactured and tested in compliance with FDA’s strict Medical Device Quality System Regulations (QSR) and current Good Manufacturing Practices (cGMP). This ensures exceptional integrity and consistency and provides quality-controlled products.

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