FDA Approves Divine 9 With Carragel

FDA Approves Divine 9 With Carragel

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.

Related:  

Copyright © 2025 Adnet Media. All Rights Reserved. XBIZ is a trademark of Adnet Media.
Reproduction in whole or in part in any form or medium without express written permission is prohibited.

More News

Sportsheets Releases New Training Video for 'Peaches 'n CreaMe' Collection

Sportsheets has released its latest training video, titled "Peaches ’n CreaMe," hosted by Brand Ambassador Rin Musick.

Full Circle Names Stefanie Neumann Sales Account Executive

Pleasure brand Full Circle has appointed Stefanie Neumann as its new sales account executive.

Pjur Sponsors Düsseldorf's Sex Now Exhibition

Pjur is sponsoring Sex Now Exhibition at NRW-Forum in Düsseldorf, running through May 3, 2026.

Angelface Baddies Debuts 'Daddies for Baddies' Line

Wellness brand Angelface Baddies has introduced its new Daddies for Baddies line of men's wellness products.

Orion Debuts 'RC Vibrating Butt Plug' From 'Anos' Line

Orion Wholesale has introduced the RC Vibrating Butt Plug with Flexible Arms from its Anos line.

Playharda Wholesale, Pure Envy Ink European Distribution Deal

Playharda Wholesale has signed a deal with pleasure brand Pure Envy for distribution in the U.K. and Europe.

XR Brands Launches 'Creature Cocks' Line

XR Brands has introduced its new Creature Cocks collection of men's underwear.

Tenga Launches 2025 Christmas Advent Calendar

Pleasure brand Tenga has launched a 2025 Christmas Advent calendar, now available for pre-order.

The Dungeon Store Debuts 'Thing Noir' Violet Wand Attachment

The Dungeon Store has released the Thing Noir violet wand conductive e-stim accessory.

Pjur, Magasin du Nord Partner for 'Flex Area' Campaign

Pjur and retail brand Magasin du Nord have partnered for the wellness brand’s Flex Area campaign.

Show More