Cleared Traditional

K150886 - Trojan Riviera Personal Lubricant

K150886 is an FDA 510(k) clearance for Trojan Riviera Personal Lubricant, manufactured by Church & Dwight Co., Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code NUC cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K150886 · Church & Dwight Co., Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2015
Decision
109d
Days
Class 2
Risk

K150886 is an FDA 510(k) clearance for the Trojan Riviera Personal Lubricant. Classified as Lubricant, Personal (product code NUC), Class II - Special Controls.

Submitted by Church & Dwight Co., Inc. (Ewing, US). The FDA issued a Cleared decision on July 20, 2015 after a review of 109 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5300 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Church & Dwight Co., Inc. devices

FDA 510(k) Submission Details - K150886

510(k) Number K150886 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2015
Decision Date July 20, 2015
Days to Decision 109 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 160d · This submission: 109d
Pathway characteristics
Predicate-based equivalence.

NUC Device Classification - Class 2, Special Controls

Product Code NUC Lubricant, Personal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5300
Definition 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Obstetrics & Gynecology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT02297841 Completed Interventional Industry-sponsored

Repeated Insult Patch Test of Personal Lubricants

209
Patients (actual)
Screening
Purpose
Open label
Masking
Condition studied Erythema; Edema
Study design Single group
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Sponsor Church & Dwight Company, Inc. (industry)
Started 2014-11-01 → Primary completion 2014-12-01
Primary outcome
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
View full study on ClinicalTrials.gov

Regulatory Peers - NUC Lubricant, Personal

All 212
Devices cleared under the same product code (NUC) and FDA review panel - the closest regulatory comparables to K150886.
OneTouch Lubricant Gel
K142790 · Thai Nippon Rubber Industry Co., Ltd. · Jul 2015
O Glide Personal Lubricant
K142726 · Grafenberg Labs · Jul 2015
Medline Natural Lubricating Liquid
K143322 · Medline Industries, Inc. · Jul 2015
JO H20 Water Based Personal Lubricant
K150480 · United Consortium, Inc. · Jul 2015
K-Y BRAND TOUCH All-in-one Warming Caressing Creme and Personal Lubricant
K143511 · Reckitt Benckiser · May 2015
Vaginal Moisturizing Gel
K150615 · Combe Incorporated · May 2015