Cleared Traditional

Trojan Chain Reaction Personal Lubricant

K161544 · Church & Dwight Co., Inc. · Obstetrics & Gynecology

Aug 2016

Decision

89d

Days

Class 2

Risk

About This 510(k) Submission

K161544 is an FDA 510(k) clearance for the Trojan Chain Reaction Personal Lubricant, a Lubricant, Personal (Class II — Special Controls, product code NUC), submitted by Church & Dwight Co., Inc. (Ewing, US). The FDA issued a Cleared decision on August 31, 2016, 89 days after receiving the submission on June 3, 2016. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5300.

Submission Details

510(k) Number	K161544 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 03, 2016
Decision Date	August 31, 2016
Days to Decision	89 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF

Device Classification

Product Code	NUC — Lubricant, Personal
Device Class	Class II — 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.