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510(k) Data Aggregation
K Number
K152168Device Name
Love Liquid Personal Lubricant
Manufacturer
Date Cleared
2016-02-05
(185 days)
Product Code
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
The Kama Sutra Company
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Love Liquid® 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 and Polyisoprene condoms. It is not compatible with polyurethane condoms.
Device Description
The Love Liquid® Personal Lubricant is a non-sterile; water based personal lubricant, an over-the-counter personal lubricant, formulated to be a clear, non-irritating, non-greasy, liquid and odorless, aqueousbased. The proposed device contains a blend of ingredients found in the predicate device. The device is designed to supplement the body's own natural lubrication fluids and is compatible for use with or without a latex condom during intimate sexual activity as evidenced by condom compatibility testing. The device formula is neither a contraceptive nor a spermicide.
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