Trojan Riviera Personal Lubricant

FDA 510(k) K150886 · Church & Dwight Co., Inc.

Substantially Equivalent

510(k) numberK150886

Submission

Device name
Trojan Riviera Personal Lubricant
Applicant
Church & Dwight Co., Inc.
Ewing, NJ, US
Received
April 2, 2015
Decision date
July 20, 2015
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NUC – Lubricant, Personal
Device class
Class II (moderate risk)
Regulation
21 CFR 884.5300
Specialty
Obstetrics/Gynecology

This device 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 may or may not be compatible with natural rubber latex, polyisoprene, and/or polyurethane condoms.

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Questions and answers

When was Trojan Riviera Personal Lubricant cleared by the FDA?

Trojan Riviera Personal Lubricant (K150886) received a 510(k) decision of Substantially Equivalent on July 20, 2015, 109 days after the submission was received.

What is the product code of K150886?

The FDA product code is NUC – Lubricant, Personal, a Class II (moderate risk) device regulated under 21 CFR 884.5300.