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510(k) Data Aggregation
K Number
K140304Device Name
SIMPLY SLICK PERSONAL LUBRICATING LOTION
Manufacturer
Date Cleared
2014-10-07
(242 days)
Product Code
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
SIMPLY SOLUTIONS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Simply Slick™ Personal Lubricating Lotion is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex, polyurethane, and synthetic polyisoprene condoms.
Device Description
Device specifications include pH, viscosity, preservation effectiveness, appearance, odor, and testing for bioburden, aerobes, fungi, spore, and obligate anaerobe. It is a biocompatible, water soluble, white, viscous liquid and is non-sterile. It is neither a contraceptive nor a spermicide and is sold over-the-counter in a 2 oz / 59 ml polyethylene squeeze bottle with a screw-on, disc press-flip up cap. A cap liner is placed over the opening of the bottle before the lid is screwed on the bottle. One bottle is placed into a plastic display carton which constitutes the device outer packaging. Simply Slick™ Personal Lubricating Lotion is a non-greasy and fragrance-free formulation and is to be stored at room temperature.
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