Divine 9 personal lubricants have shown to be highly effective in the prevention of the human papilloma viruses (HPVs). HPV is the world’s most common sexually transmitted disease. Our mission is to deliver naturally-derived products that protect, prevent and enhance the quality of life.
McGill University’s Division of Cancer Epidemiology, in coordination with the National Cancer Institute (NCI) have selected Divine 9 personal lubricants for independent laboratory testing. The clinical trials are showing promising results of the prevention of HPV associated diseases such as cervical, vaginal, anal and throat cancer as well as genital warts.
- HPV is difficult to detect and spreads easily
- 80% of woman will be infected sometime in their lifetime
- 50% of all actively gay men are infected right now
Divine 9 is the only lubricant in the world undergoing studies such as these
“Carrageenan”, a special type of sea algae extract, is a natural infection inhibitor scientifically formulated by Divine. The company’s proprietary formula called Carragel TM has designed the ultra-premium personal lubricant for the prevention of all HPV(s) and your pleasure. The potential HPV benefits combined with its gentle feel and hypo-allergenic formula leads us to recommend Divine 9 to all.
- personal lubricant that defines a new category
- water-based, fragrance, paraben, glycerin-free
- non-staining and latex safe
- natural & intimate feel that leaves the skin soft and smooth
FDA Approves Divine 9® with CarraShield™ Personal Lubricant as a Class II Medical Device
CarraShield Labs, Inc. announced today the U.S. Food and Drug Administration (FDA) has completed its evaluation of Divine 9® personal lubricant made with CarraShield™ and has approved it as a Class II Medical Device. Divine 9 with CarraShield is the first and only personal lubricant formulated with carrageenan, a type of sea algae extract, to be FDA-approved. The official notification can be found on the FDA website.
January 6, 201 6, Orlando, Florida – CarraShield Labs, Inc. announced today 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 the first and only personal lubricant formulated with carrageenan to be FDA approved. Carrageenan is a sea algae extract used in many food products and 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 now requires all lubricants to have a Class II Medical Device 51 0(k) clearance. A 51 0(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 stringent safety and performance standards. Divine 9 with CarraShield successfully completed a complex battery of tests that included:
• Condom compatibility
• Microbial presence
• Preservative effectiveness
• Vaginal irritation
• Acute system toxicity
• Cellular toxicity
• Skin sensitivity
• Vaginal irritation
FDA-Approved Testing Confirms Divine 9® made with CarraShield™ Meets All Personal Lubricant Recommendations of the World Health Organization (WHO)
CarraShield Labs, Inc. reported today that with the successful conclusion of the product testing required by the U.S. Food and Drug Administration for approval as a Class II Medical Device, Divine 9® made with CarraShield™ also meets or exceeds all the recommendations for personal lubricants published by the World Health Organization. The World Health Organization (WHO) published an Advisory Note providing four key guidelines for the purchase of personal lubricants. Divine 9 with Carragel meets or exceeds all of the recommended guidelines.
January 6, 2016, Orlando, Florida – CarraShield Labs, Inc. reported today that with the conclusion of the product testing required by the U.S. Food and Drug Administration for approval as a Class II Medical Device, Divine 9® made with CarraShield™ was also shown to meet or exceed all the recommendations
for personal lubricants published by the World Health Organization.