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510(k) Data Aggregation
K Number
K181078Device Name
The Sex Gel
Manufacturer
Necessaire, Inc.
Date Cleared
2018-09-10
(139 days)
Product Code
NUC
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
Necessaire, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sex Gel 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 latex, polyisoprene, and polyurethane condoms.
Device Description
The Sex Gel is a non-sterile, water-based, over-the-counter personal lubricant, formulated to be a clear liquid. The device contains a blend of ingredients similar to 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 natural rubber latex, polyisoprene, or polyurethane condoms during intimate sexual activity. The device formula is neither a contraceptive nor a spermicide.
The product is packaged in (50 ml / 1.7 oz) bottles made from high density polypropylene (POLY WHITE P 8555). The bottle is fitted with a pump for dispensing lubricant made of polypropylene, butyl, and steel. Each bottle is packaged in a paperboard carton, which constitutes the device's individual carton.
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