Cleared Special

K-Y BRAND WARMING LIQUID

K070545 · Personal Products Co. · Obstetrics & Gynecology

Mar 2007

Decision

25d

Days

Class 2

Risk

About This 510(k) Submission

K070545 is an FDA 510(k) clearance for the K-Y BRAND WARMING LIQUID, a Lubricant, Personal (Class II — Special Controls, product code NUC), submitted by Personal Products Co. (Skillman, US). The FDA issued a Cleared decision on March 23, 2007, 25 days after receiving the submission on February 26, 2007. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5300.

Submission Details

510(k) Number	K070545 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 26, 2007
Decision Date	March 23, 2007
Days to Decision	25 days
Submission Type	Special
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.