KMJ · Class I · 21 CFR 880.6375

FDA Product Code KMJ: Lubricant, Patient

Leading manufacturers include Span-America Medical Systems, Inc., General Medical Co. and Abco Dealers, Inc..

49
Total
49
Cleared
101d
Avg days
1977
Since

FDA 510(k) Cleared Lubricant, Patient Devices (Product Code KMJ)

49 devices
1–24 of 49
Cleared Apr 13, 2015
Lubricating Jelly
K142473
Sion Biotext Medical , Ltd.
General Hospital · 222d
Cleared Jul 24, 2014
COLONGLIDE LUBRICANT
K141028
Pediatric Pharmaceuticals, Inc.
General Hospital · 93d
Cleared Oct 03, 2013
COLONGLIDE(R) LUBRICANT
K131617
Pediatric Pharmaceuticals, Inc.
General Hospital · 122d
Cleared Aug 10, 2012
LUBE JELLY SURINGE
K121390
Nurse Assist, Inc.
General Hospital · 93d
Cleared May 04, 2012
DUKAL LUBRICATING JELLY
K113689
Dukal Corporation
General Hospital · 141d
Cleared Apr 10, 2012
STERILE LUBRICATING JELLY
K112110
Jianerkang Medical Dressing Company
General Hospital · 263d
Cleared May 10, 2011
DYNACOR LUBRICATION GEL
K103718
Medline Industries, Inc.
General Hospital · 140d
Cleared Dec 23, 2010
ULTRA SEAL STERILE LUBRICATING JELLY
K101522
Ultra Seal Corporation
General Hospital · 204d
Cleared Dec 18, 2009
DYNAREX STERILE LUBRICATING JELLY
K092488
Dynarex Corporation
General Hospital · 127d
Cleared Nov 21, 2008
STERI-LUB LUBRICATION GEL
K083189
Avail Medical Products, Inc.
General Hospital · 23d
Cleared May 22, 2008
SHEFFIELD PHARMACEUTICALS (STERILE) LUBRIGEL
K073684
Sheffield Industries, Div. of Faria , Ltd.
General Hospital · 146d
Cleared Apr 03, 2008
SPIRUS MEDICAL SURGICAL INSTRUMENT
K080042
Spirus Medical, Inc.
General Hospital · 86d
Cleared Feb 23, 2005
DUREX PLAY WARMER LUBRICANT
K042563
Ssl Americas, Inc.
General Hospital · 155d
Cleared May 07, 2004
E-Z LUBRICATING JELLY
K041060
Chester Labs, Inc.
General Hospital · 14d
Cleared Jan 24, 2003
GOOD LUBRICATIONS
K020586
Biofilm, Inc.
General Hospital · 336d
Cleared Jan 16, 1998
PDI STERILE LUBRICATING JELLY
K974768
Nice-Pak Products, Inc.
General Hospital · 25d
Cleared Oct 10, 1997
LUBRIGLIDE
K973557
Qualis, Inc.
General Hospital · 21d
Cleared Jul 18, 1996
LUBRICATING JELLY, LOW VISCOSITY
K961502
Span-America Medical Systems, Inc.
General Hospital · 90d
Cleared Jun 26, 1996
EVRON GEL
K961222
Pharmaceutical Innovations, Inc.
Radiology · 90d
Cleared Jul 21, 1995
AQUAGEL LUBRICATING JELLY
K951431
Depuy Healthcare
General Hospital · 116d
Cleared Jul 19, 1995
MAXILUBE
K943010
Mission Pharmacal Co.
General Hospital · 390d
Cleared Feb 27, 1995
STERI-LUB LUBRICATION GEL
K944969
Horizon Medical, Inc.
General Hospital · 139d
Cleared Feb 18, 1994
ASTROGLIDE
K935299
Biofilm, Inc.
General Hospital · 108d
Cleared Feb 19, 1993
COMFORT PERSONAL LUBRICANT
K915574
Hyman, Phelps & McNamara, P.C.
General Hospital · 435d

About Product Code KMJ - Regulatory Context