Orlando, Florida (PRWEB)
January 07, 2016
CarraShield Labs, Inc. (http://www.carrashieldlabs.com) announced currently a U.S. Food and Drug Administration (FDA) has finished a analysis of Divine 9® personal liniment done with CarraShield™ and has authorized it as a Class II Medical Device. Divine 9 with CarraShield is a initial and usually personal liniment formulated with carrageenan to be FDA approved. Carrageenan is a sea algae remove used in many food products and CarraShield Labs has grown a exclusive carrageenan called Carragel privately for use in personal lubricants.
In sequence for a personal liniment to be marketed and sole in a United States, a FDA now requires all lubricants to have a Class II Medical Device 510(k) clearance. A 510(k) is a premarket acquiescence done to FDA to denote that a device to be marketed is during slightest as protected and effective as other products already on a market. CarraShield Labs used eccentric laboratories to uncover that Divine 9 personal liniment meets difficult reserve and opening standards. Divine 9 successfully finished a formidable battery of tests that included:
- Condom compatibility
- Antimicrobial effectiveness
- Microbial presence
- Preservative effectiveness
- Vaginal irritation
- Acute complement toxicity
- Cellular toxicity
- Skin sensitivity
- Vaginal exasperation
The central presentation of a capitulation of Divine 9 with CarraShield can be found on a FDA website during http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K150397.
The FDA has been evenly reviewing all personal lubricants on a marketplace with a vigilant of requiring products labeled as a “personal lubricant” to obtain a 510(k) status. “With a FDA mandate so despotic and a contrast routine so demanding, we trust many products that call themselves a personal liniment will shortly be off a market,” settled Dean Fresonke, CEO of CarraShield Labs. “While provision a compulsory information was demanding, we knew a naturally-derived products would simply accommodate a compulsory FDA reserve standards.”
About CarraShield Labs, Inc.
CarraShield Labs, Inc., combines inlet with scholarship to emanate products that urge passionate well-being. Intensive investigate has led to a company’s proprietary, naturally-derived sea algae combine called CarraShield™. Divine 9® with CarraShield showed guarantee in restraint a delivery of cancer-causing HPV infection in government-sponsored laboratory studies and is now undergoing tellurian clinical trials during 3 apart university medical investigate centers. While a health advantages of CarraShield are being studied, we can suffer a exotic, erotic feel of Divine 9 today. Look for Divine 9 personal lubricants and other products done with CarraShield in health unwavering stores and websites. Learn some-more during http://www.carrashieldlabs.com.
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