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
193–216 of 247
Cleared Oct 16, 2012
ME AGAIN(R) LONG LASTING VAGINAL MOISTURIZER, VH ESSENTIALS (R) LONG LASTING VAGINAL MOISTURIZER
K112217
Polichem S.A
Obstetrics & Gynecology · 441d
Cleared Oct 04, 2012
NIRVANA A PERSONAL LUBRICANT
K120706
Church & Dwight Co., Inc.
Obstetrics & Gynecology · 210d
Cleared Oct 03, 2012
NIRVANA B PERSONAL LUBRICANT
K120751
Church & Dwight Co., Inc.
Obstetrics & Gynecology · 205d
Cleared Jul 11, 2012
POISE PERSONAL LUBRICANT
K120650
Kimberly Clark Corporation
Obstetrics & Gynecology · 131d
Cleared Mar 28, 2012
ONE PERSONAL LUBRICANT (SILICONE)
K110690
One
Obstetrics & Gynecology · 383d
Cleared Feb 01, 2012
ONE PERSONAL LUBRICANT (WATER BASED)
K110691
One
Obstetrics & Gynecology · 327d
Cleared Dec 08, 2011
AQUA LUBE
K110325
Mayer Laboratories, Inc.
Obstetrics & Gynecology · 308d
Cleared Jan 25, 2008
GLYCERIN & PARABEN FREE ASTROGLIDE
K072647
Biofilm, Inc.
Obstetrics & Gynecology · 128d
Cleared Mar 23, 2007
K-Y BRAND WARMING LIQUID
K070545
Personal Products Co.
Obstetrics & Gynecology · 25d
Cleared Dec 08, 2006
K-Y BRAND INTRIGUE
K062796
Personal Products Co.
Obstetrics & Gynecology · 80d
Cleared Jul 12, 2006
FOR PLAY, SLIP, PREPAIR - PERSONAL LUBRICANTS
K051688
Trimensa Pharmaceuticals
Obstetrics & Gynecology · 384d
Cleared Feb 15, 2006
I-D GLIDE
K051295
Westridge Laboratories, Inc.
Obstetrics & Gynecology · 273d
Cleared Aug 31, 2005
O'MY NATURAL LUBRICANT, O'MY NATURAL FLAVORED LUBRICANT
K042915
O'My Products Incorporated
Obstetrics & Gynecology · 314d
Cleared Jul 08, 2005
THE ART OF INTIMACY RESPONSE PERSONAL LUBRICANT
K051668
Goodmark USA, Inc.
Obstetrics & Gynecology · 16d
Cleared Apr 08, 2005
DUREX PLAY TINGLING LUBRICANT
K042958
Ssl Americas, Inc.
Obstetrics & Gynecology · 163d
Cleared Mar 17, 2005
PERSONAL WARMING GEL
K050211
Qualis, Inc.
Obstetrics & Gynecology · 45d
Cleared Mar 17, 2005
PERSONAL WARMING JELLY
K050212
Qualis, Inc.
Obstetrics & Gynecology · 45d
Cleared Sep 24, 2004
PERSONAL LUBRICATING GEL
K041129
Qualis, Inc.
Obstetrics & Gynecology · 147d
Cleared Mar 05, 2002
TROJAN PASSION BERRY GEL
K013433
Armkel, LLC
Obstetrics & Gynecology · 140d
Cleared Feb 01, 2002
TROJAN CRYSTAL CLEAR LIQUID
K013614
Armkel, LLC
Obstetrics & Gynecology · 88d
Cleared Mar 09, 2001
EXAM ROOM ASTROGLIDE (PROFESSIONAL MARKET), TARGET LUBRICATING JELLY (OTC CONSUMER MARKET)
K003867
Biofilm, Inc.
Obstetrics & Gynecology · 87d