NUC · Class II · 21 CFR 884.5300

FDA Product Code NUC: Lubricant, Personal

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.

Leading manufacturers include Biofilm, Inc., United Consortium and CC Wellness, LLC.

247
Total
247
Cleared
185d
Avg days
2000
Since
247 devices
169–192 of 247
Cleared Mar 09, 2015
ID MILLENNIUM, ID MOMENTS SILICONE
K141767
Westridge Laboratories, Inc.
Obstetrics & Gynecology · 251d
Cleared Feb 19, 2015
Lubrigyn cream
K150147
Uniderm Farmaceutici Srl
Obstetrics & Gynecology · 28d
Cleared Dec 17, 2014
DUREX REALFEEL PLEASURE GEL PERSONAL LUBRICANT
K131643
Reckitt Benckiser, LLC
Obstetrics & Gynecology · 560d
Cleared Nov 13, 2014
INTERNAL HYDRATING GEL
K141718
Combe Incorporated
Obstetrics & Gynecology · 141d
Cleared Nov 04, 2014
DUREX EMBRACE PERSONAL LUBRICANT
K140193
Reckitt Benckiser, LLC
Obstetrics & Gynecology · 281d
Cleared Oct 30, 2014
ASTROGLIDE SENSUAL STRAWBERRY
K140590
Biofilm, Inc.
Obstetrics & Gynecology · 237d
Cleared Oct 07, 2014
SIMPLY SLICK PERSONAL LUBRICATING LOTION
K140304
Simply Solutions, LLC
Obstetrics & Gynecology · 242d
Cleared Aug 22, 2014
LUBRIGYN CREAM
K132772
Uniderm Farmaceutici Srl
Obstetrics & Gynecology · 351d
Cleared Aug 06, 2014
ASTROGLIDE NATURAL
K141581
Biofilm, Inc.
Obstetrics & Gynecology · 54d
Cleared Jul 24, 2014
PJUR(R) SILICONEGEL, PJUR(R) BASIC PERSONAL GLIDE, PJUR(R) LIGHT, PJUR(R) MED PREMIUM GLIDE
K133336
Pjur Group Luxembourg S.A.
Obstetrics & Gynecology · 268d
Cleared Jul 21, 2014
AZUL PERSONAL LUBRICANT
K141034
Church & Dwight Co., Inc.
Obstetrics & Gynecology · 90d
Cleared Jul 18, 2014
PJUR ORIGINAL, PJUR WOMAN, PJUR MAN EXTREME GLIDE
K133233
Pjur Group Luxembourg S.A.
Obstetrics & Gynecology · 270d
Cleared Jun 11, 2014
JO PREMIUM PERSONAL LUBRICANT
K132954
United Consortium
Obstetrics & Gynecology · 264d
Cleared Nov 08, 2013
K-Y BRAND LIQUIBEADS
K122061
Johnson & Johnson Healthcare Products
Obstetrics & Gynecology · 483d
Cleared Sep 13, 2013
SASMAR ORIGINAL, SASMAR CLASSIC
K131084
Sasmar, Inc.
Obstetrics & Gynecology · 148d
Cleared Aug 30, 2013
ALOE CADABRA LUBRICANT, ALOE CADABRA FLAVORED/SCENTED LUBRICANTS
K124044
Seven Oaks Ranch, Inc.
Obstetrics & Gynecology · 242d
Cleared Aug 22, 2013
WET PLATINUM PERSONAL LUBRICANT
K130012
Trigg Laboratories, Inc.
Obstetrics & Gynecology · 232d
Cleared Aug 01, 2013
AQUA LUBE NATURAL LUBRICANT - REGULAR, WARMING
K130345
Mayer Laboratories, Inc.
Obstetrics & Gynecology · 171d
Cleared Jun 28, 2013
NIRVANA D PERSONAL LUBRICANT (TBD)
K123427
Church & Dwight Co., Inc.
Obstetrics & Gynecology · 233d
Cleared Apr 09, 2013
WARMING JELLY PERSONAL LUBRICANT
K123770
Wisconsin Pharmacal Co., LLC
Obstetrics & Gynecology · 123d
Cleared Mar 07, 2013
LIFESTYLES SMOOTH 2-IN-1 MASSAGE & LUBRICANT
K122476
Ansell Healthcare Products, LLC
Obstetrics & Gynecology · 205d
Cleared Feb 22, 2013
LIFESTYLES WARM LOVIN PERSONAL LUBRICANT
K122720
Ansell Healthcare Products, LLC
Obstetrics & Gynecology · 170d
Cleared Feb 19, 2013
LIFESTYLES LUXE PREMIUM PERSONAL LUBRICANT
K122477
Ansell Healthcare Products, LLC
Obstetrics & Gynecology · 189d
Cleared Feb 14, 2013
LIFESTYLES NATURAL PERSONAL LUBRICANT
K122054
Ansell Healthcare Products, LLC
Obstetrics & Gynecology · 216d