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510(k) Data Aggregation
K Number
K212260Device Name
Sensuva Premium Silicone Personal Lubricant
Manufacturer
Valencia Naturals, Inc
Date Cleared
2022-04-13
(267 days)
Product Code
NUC
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
Valencia Naturals, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sensuva Premium Silicone Personal Lubricant is a silicone-based personal lubricant for penile, anal 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, polyisoprene and polyurethane condoms.
Device Description
Sensuva Premium Silicone Personal Lubricant is a non-sterile, clear, colorless, thin liquid, silicone-based personal lubricant. This device is for penile, anal, 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. It is compatible with natural rubber latex, polyisoprene and polyurethane condoms. Its formulation consists of dimethicone, dimethiconol, and cyclopentasiloxane. Sensuva Premium Silicone Personal Lubricant is sold as an over-the-counter (OTC) device and is provided in polyethylene terephthalate bottles. The 1.93 fl. oz./57 mL bottles are fitted with 20/410 smooth black pump sprayers and clear polypropylene caps. The 4.23 fl. oz./125 mL and 8.12 fl. oz./240 mL bottles are capped with 24/410 smooth black lotion pumps.
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