Divine 9 Meets Recommendations of World Health Organization

Divine 9 Meets Recommendations of World Health Organization

ORLANDO — CarraShield Labs reports 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, its lubricant Divine 9 made with CarraShield was also shown to meet or exceed all the recommendations for personal lubricants published by the World Health Organization.

The World Health Organization (WHO), Department of Reproductive Health and Research, in collaboration with United Nations Population Fund (UNFPA), published an Advisory Note providing guidelines for the purchase of personal lubricants. The objective of the WHO Advisory Note was to establish criteria based on recently published studies that help ensure a lubricant will not weaken condoms, contain any potentially harmful ingredients, or be formulated in a way that negatively effects sensitive tissue inside the body.

Although the WHO has not specifically tested Divine 9, Carrashield Labs says it meets the following recommendations from WHO’s Advisory Note:

 “When procuring water-based lubricants, the osmolality should preferably be 1200 mOsm/kg or less.”

Studies referenced by WHO in the Advisory Note suggest that lubricants with high osmolality might cause damage to the walls of the vagina and anus. CarraShield Labs says its Divine 9 with Carragel was shown by FDA-approved laboratory testing to have an osmolality ranging between 520 and 720 mOsm/kg, a value below the WHO-recommended maximum.

“Lubricants containing polyquaternary compounds should be avoided until there is further evidence on the effect of polyquaternium compounds on HIV replication rates.”

The WHO cited studies that suggest polyquaternium compounds may enhance the replication of HIV. Polyquaternium compounds are used in some silicone-based lubricants. CarraShield Labs says Divine 9 with CarraShield contains no polyquaternary compounds specifically, and no silicone-based ingredients in general. The primary ingredients in Divine 9 are a natural sea algae extract and purified water.

“For lubricants intended primarily for MSM (men who have sex with men) or where the nature of the intended use cannot be ascertained, a pH in the range 5.5 to 7 is recommended. Lubricants with pH exceeding 7 are not recommended.”

According to the company, Divine 9 with Carragel has a pH of 6.5. CarraShield Labs says it uses natural citric acid to precisely adjust the pH in every batch.

“The bulk procurement and distribution of lubricants containing spermicides, medicinal and other active substances is not recommended.”

The Advisory Note cites studies that suggest spermicides (predominantly nonoxynol-9) have significant irritation issues and that medicinal additives such as benzocaine (to reduce sensation) have additional regulatory requirements as medicines. According to the company, Divine 9 with Carragel contains no spermicides, no medicinal additives nor does it contain any type of herb or chemical that attempts to create stimulating, warming, tingling or other effects.

“The team at CarraShield Labs has been working diligently with independent testing labs to validate the safety of Divine 9 with CarraShield for the FDA,” explained Dean Fresonke, CEO of CarraShield Labs. “With the data now in hand and validated through our approval as a Class II Medical Device by the FDA, we are gratified to report that we not only meet all the FDA requirements but also meet or exceed the World Health Organization’s published guidelines for personal lubricants.”

Related:  

Copyright © 2024 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

Xgen Now Shipping ZOLO's 'Stroke Off' Collection

Xgen Products is now shipping the Stroke Off collection of 11 handheld strokers and four masturbators modeled after lifelike body parts.

Nobü Unveils 'Gyrä' Vibrating Grinding Pad

Nobü has introduced the new Gyrä vibrating grinding pad.

Orion Introduces New 3-Motor Vibrator From 'Sweet Smile' Line

Orion Wholesale has debuted the new three-motor RC G- & P-Spot Vibrator from its Sweet Smile line.

C1R Debuts 'Vers' Suction Dildo, Butt Plug

C1R has introduced its new Vers liquid silicone suction dildo and butt plug.

Blush Erotica, The Kinky Candle Company Partner for Branded Candle

Blush Erotica has partnered with The Kinky Candle Company for an official branded candle.

Violet Voss to Collaborate With IronTech Doll on Realistic Replica

Violet Voss has signed an exclusive deal with IronTech Doll to create a sex doll modeled after her.

Honey's Place Now Shipping 'Teacher's Pet' Collection From Xgen Products

Honey’s Place is now distributing the Teacher's Pet collection from Xgen Products.

Zini Releases Reimagined Version of 'Roae+' Toy

Zini is reintroducing its brand with the release of the latest reiteration of its Roae+ signature toy.

Hustler Hollywood, 'Shameless Sex' Team Up for Workshop Series

"Shameless Sex" podcast hosts Amy Baldwin and April Lampert have joined forces with Hustler Hollywood for a workshop series titled “Shameless Ways [for Couples] to Have More Pleasure.”

SexToyDistributing Now Shipping New BDSM Furniture From XR Brands

SexToyDistributing is shipping three new pieces of BDSM furniture from XR Brands' Master Series line.

Show More