Cleared Traditional

K122720 - LIFESTYLES WARM LOVIN PERSONAL LUBRICANT

K122720 is the FDA 510(k) clearance for LIFESTYLES WARM LOVIN PERSONAL LUBRICANT by Ansell Healthcare Products, LLC. It is a Class 2 Obstetrics & Gynecology device (product code NUC) cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K122720 · Ansell Healthcare Products, LLC · Obstetrics & Gynecology device
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Feb 2013
Decision
170d
Days
Class 2
Risk

K122720 is an FDA 510(k) clearance for the LIFESTYLES WARM LOVIN PERSONAL LUBRICANT. Classified as Lubricant, Personal (product code NUC), Class II - Special Controls.

Submitted by Ansell Healthcare Products, LLC (San Luis Obispo, US). The FDA issued a Cleared decision on February 22, 2013 after a review of 170 days - an extended review cycle.

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 Ansell Healthcare Products, LLC devices

Submission Details

510(k) Number K122720 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2012
Decision Date February 22, 2013
Days to Decision 170 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 160d · This submission: 170d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - NUC Lubricant, Personal

All 121
Devices cleared under the same product code (NUC) and FDA review panel - the closest regulatory comparables to K122720.
K-Y Silicone
K173504 · Reckitt Benckiser, LLC · Jan 2018
UltraSmooth Lubricating Liquid, and Medline Lubricating Liquid and Vaginal Moisturizer
K143529 · Medline Industries, Inc. · Aug 2015
Medline Natural Lubricating Liquid
K143322 · Medline Industries, Inc. · Jul 2015
K-Y BRAND WARMING LIQUID
K070545 · Personal Products Co. · Mar 2007
K-Y BRAND INTRIGUE
K062796 · Personal Products Co. · Dec 2006
TROJAN PASSION BERRY GEL
K013433 · Armkel, LLC · Mar 2002