KMJ · Class I · 21 CFR 880.6375

FDA Product Code KMJ: Lubricant, Patient

Leading manufacturers include Span-America Medical Systems, Inc., Biofilm, Inc. and Pediatric Pharmaceuticals, 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 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 Feb 18, 1994
ASTROGLIDE
K935299
Biofilm, Inc.
General Hospital · 108d
Cleared May 03, 1991
MENTOR LUBRICATING JELLY
K910790
Mentor Corp.
General Hospital · 67d
Cleared Sep 09, 1988
MODIFIED AMERICAN LUBRICATING JELLY, 2.7 & 5.0
K882506
Span-America Medical Systems, Inc.
General Hospital · 92d
Cleared Jun 05, 1987
AMERICAN LUBRICATING JELLY STERILE 2.7G & 5G
K870742
Span-America Medical Systems, Inc.
General Hospital · 100d
Cleared Dec 01, 1986
AQUALUBE(TM)
K864556
Parker Laboratories, Inc.
General Hospital · 12d
Cleared Dec 10, 1985
STERILE SALINE SOLUTION
K854155
I M, Inc.
General Hospital · 60d
Cleared Jul 30, 1982
TOMAC LUBRICATING JELLY
K822143
American Medical Systems, Inc.
General Hospital · 9d
Cleared Mar 26, 1982
WET PACK LINE OF PRODUCTS
K820587
Abco Dealers, Inc.
General Hospital · 22d
Cleared Sep 28, 1981
A.D.T. PROCEDURES TRAY
K812297
A.D.T. Lab Industries
General Hospital · 45d
Cleared Apr 21, 1981
PEDICAT*
K810049
Pollak (Intl.), Ltd.
General Hospital · 98d

About Product Code KMJ - Regulatory Context