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510(k) Data Aggregation
K Number
K182027Device Name
Wet Organics Personal Lubricant
Manufacturer
Trigg Laboratories DBA Wet International
Date Cleared
2018-11-21
(114 days)
Product Code
NUC
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
Trigg Laboratories DBA Wet International
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Wet Organics 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. The product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
Device Description
The Wet Organics Personal Lubricant is a non-sterile, water-based, over-the-counter personal lubricant. The proposed device contains a blend of organic aloe and other ingredients similar to ingredients found in the predicate device.
The device is designed to supplement the body's own natural lubrication fluids during intimate sexual activity. The device is also compatible for use with natural rubber latex and polyisoprene condoms. The device is neither a contraceptive nor a spermicide.
The Wet Organics Personal Lubricant is packaged in 3 oz. polyethylene terephthalate bottle with a dispensing bottle cap with a disc top.
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