ORLANDO — CarraShield Labs, Inc. announced today that the U.S. Food and Drug Administration (FDA) has completed its evaluation of Divine 9 personal lubricant made with CarrraShield and has approved it as a Class II Medical Device.
Divine 9 with CarraShield is formulated with carrageenan, which is a sea algae extract used in food products. CarraShield Labs has developed a proprietary carrageenan called CarraShield specifically for use in personal lubricants.
In order for a personal lubricant to be marketed and sold in the United States, the FDA requires all lubricants to have a Class II Medical Device 510(k) clearance. A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective as other products already on the market.
CarraShield Labs used independent laboratories to show that Divine 9 personal lubricant meets safety and performance standards. Divine 9 with CarraShield successfully completed a complex battery of tests that included: condom compatibility, antimicrobial effectiveness, microbial presence, preservative effectiveness, vaginal irritation, acute system toxicity, cellular toxicity, skin sensitivity, vaginal irritation, and osmolality.
The official notification of the approval of Divine 9 with CarraShield can be found on the FDA website.
“With the FDA requirements so strict and the testing process so demanding, we believe many products that call themselves a personal lubricant will soon be off the market,” said Dean Fresonke, CEO of CarraShield Labs. “While supplying the necessary data was demanding, we knew our naturally-derived products would easily meet the required safety standards.”
For more information, contact Jeff Hawkins at (310) 720-0215, or email jeff@divine9lubricants.com.
