Lubricant, Patient
FDA product code KMJ · Class I (low risk) · 21 CFR 880.6375 · General Hospital
49510(k) clearances
0PMA approvals
17recalls
Manufacturers
- Span-America Medical Systems, Inc. 3
- Biofilm, Inc. 2
- Abco Dealers, Inc. 2
- Pediatric Pharmaceuticals, Inc. 2
- General Medical Co. 2
- Osbon Medical Systems, Ltd. 2
- I M, Inc. 1
- Gam-Med Packaging Corp. 1
- Upsher-Smith Laboratories, Inc. 1
- Sion Biotext Medical , Ltd. 1
- H & P Industries, Inc. 1
- Parker Laboratories, Inc. 1
- Codman & Shurtleff, Inc. 1
- Huntington Laboratories, Inc. 1
- Vli Corp. 1
- American Medical Systems, Inc. 1
- A.D.T. Lab Industries 1
- Johnson & Johnson Professionals, Inc. 1
- Pollak (Intl.), Ltd. 1
- The Hygenic Corp. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K142473 | Lubricating JellyKMJ · Traditional | Sion Biotext Medical , Ltd. | 04/13/2015SE |
| K141028 | Colonglide LubricantKMJ · Special | Pediatric Pharmaceuticals, Inc. | 07/24/2014SE |
| K131617 | Colonglide(R) LubricantKMJ · Traditional | Pediatric Pharmaceuticals, Inc. | 10/03/2013SE |
| K121390 | Lube Jelly SuringeKMJ · Traditional | Nurse Assist, Inc. | 08/10/2012SE |
| K113689 | Dukal Lubricating JellyKMJ · Traditional | Dukal Corporation | 05/04/2012SE |
| K112110 | Sterile Lubricating JellyKMJ · Traditional | Jianerkang Medical Dressing Company | 04/10/2012SE |
| K103718 | Dynacor Lubrication GelKMJ · Traditional | Medline Industries, Inc. | 05/10/2011SE |
| K101522 | Ultra Seal Sterile Lubricating JellyKMJ · Traditional | Ultra Seal Corporation | 12/23/2010SE |
| K092488 | Dynarex Sterile Lubricating JellyKMJ · Traditional | Dynarex Corporation | 12/18/2009SE |
| K083189 | Steri-Lub Lubrication GelKMJ · Special | Avail Medical Products, Inc. | 11/21/2008SE |
| K073684 | Sheffield Pharmaceuticals (Sterile) LubrigelKMJ · Traditional | Sheffield Industries, Div. of Faria , Ltd. | 05/22/2008SE |
| K080042 | Spirus Medical Surgical InstrumentKMJ · Traditional | Spirus Medical, Inc. | 04/03/2008SE |
| K042563 | Durex Play Warmer LubricantKMJ · Traditional | Ssl Americas, Inc. | 02/23/2005SE |
| K041060 | E-Z Lubricating JellyKMJ · Traditional | Chester Labs, Inc. | 05/07/2004SE |
| K020586 | Good LubricationsKMJ · Traditional | Biofilm, Inc. | 01/24/2003SE |
| K974768 | Pdi Sterile Lubricating JellyKMJ · Traditional | Nice-Pak Products, Inc. | 01/16/1998SE |
| K973557 | LubriglideKMJ · Traditional | Qualis, Inc. | 10/10/1997SE |
| K961502 | Lubricating Jelly, Low ViscosityKMJ · Traditional | Span-America Medical Systems, Inc. | 07/18/1996SE |
| K961222 | Evron GelKMJ · Traditional | Pharmaceutical Innovations, Inc. | 06/26/1996SE |
| K951431 | Aquagel Lubricating JellyKMJ · Traditional | Depuy Healthcare | 07/21/1995SE |
| K943010 | MaxilubeKMJ · Traditional | Mission Pharmacal Co. | 07/19/1995SE |
| K944969 | Steri-Lub Lubrication GelKMJ · Traditional | Horizon Medical, Inc. | 02/27/1995SE |
| K935299 | AstroglideKMJ · Traditional | Biofilm, Inc. | 02/18/1994SE |
| K915574 | Comfort Personal LubricantKMJ · Traditional | Hyman, Phelps & McNamara, P.C. | 02/19/1993SE |
| K912975 | Operand Lubricating JellyKMJ · Traditional | General Medical Co. | 09/27/1991SE |
| K910790 | Mentor Lubricating JellyKMJ · Traditional | Mentor Corp. | 05/03/1991SE |
| K903910 | Lubricating JellyKMJ · Traditional | Lake Pharmaceutical, Inc. | 10/26/1990SE |
| K903717 | Dispensa-LubeKMJ · Traditional | Gam-Med Packaging Corp. | 09/06/1990SE |
| K900110 | Operand* Lubricating JellyKMJ · Traditional | General Medical Co. | 05/02/1990SE |
| K896207 | Osbon Personal LubricantKMJ · Traditional | Osbon Medical Systems, Ltd. | 12/01/1989SE |
| K895406 | Osbon Personal LubricantKMJ · Traditional | Osbon Medical Systems, Ltd. | 12/01/1989SE |
| K882506 | Modified American Lubricating Jelly, 2.7 & 5.0KMJ · Traditional | Span-America Medical Systems, Inc. | 09/09/1988SE |
| K881338 | Condom-Mate Vaginal LubricantKMJ · Traditional | Upsher-Smith Laboratories, Inc. | 05/16/1988SE |
| K872128 | K-GelKMJ · Traditional | Taro Pharmaceuticals, Inc. | 06/12/1987SE |
| K870742 | American Lubricating Jelly Sterile 2.7G & 5GKMJ · Traditional | Span-America Medical Systems, Inc. | 06/05/1987SE |
| K871169 | Lubricating JellyKMJ · Traditional | H & P Industries, Inc. | 04/01/1987SE |
| K864556 | Aqualube(Tm)KMJ · Traditional | Parker Laboratories, Inc. | 12/01/1986SE |
| K854155 | Sterile Saline SolutionKMJ · Traditional | I M, Inc. | 12/10/1985SE |
| K853653 | Sana-LubeKMJ · Traditional | Huntington Laboratories, Inc. | 11/13/1985SE |
| K851617 | Today Personal LubricantKMJ · Traditional | Vli Corp. | 06/06/1985SE |
| K822143 | Tomac Lubricating JellyKMJ · Traditional | American Medical Systems, Inc. | 07/30/1982SE |
| K820587 | Wet Pack Line of ProductsKMJ · Traditional | Abco Dealers, Inc. | 03/26/1982SE |
| K812297 | A.D.T. Procedures TrayKMJ · Traditional | A.D.T. Lab Industries | 09/28/1981SE |
| K810310 | K-Y Lubricating JellyKMJ · Traditional | Johnson & Johnson Professionals, Inc. | 04/21/1981SE |
| K810049 | Pedicat*KMJ · Traditional | Pollak (Intl.), Ltd. | 04/21/1981SE |
| K791970 | Hygenic Rubber Dam LubricantKMJ · Traditional | The Hygenic Corp. | 11/16/1979SE |
| K791243 | Lubricating JellyKMJ · Traditional | Abco Dealers, Inc. | 08/03/1979SE |
| K790087 | Lubricant, Otrho PersonalKMJ · Traditional | Ortho Pharmaceutical Corp. | 02/01/1979SE |
| K770498 | Preserve Lubricant Code No. 43=4035KMJ · Traditional | Codman & Shurtleff, Inc. | 06/20/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1635-2022 Class II | DYNAREX DynaLube LUBRICATING JELLY, STR 2.7GM (144/BX 12BX/CS) Catalog #1250Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | Mckesson Medical-Surgical Inc. Corporate… | 05/25/2022Open, Classified |
| Z-0984-2017 Class II | Medline E-Z Lubricating Jelly; Bacteriostatic. Water Soluble. Sterile. 2 FL OZ (59 ml).…Product was not sterilized. Product was shipped to distribution centers instead of the sterilization… | Medline Ind | 12/12/2016Terminated |
| Z-2249-2016 Class II | Amerigel Hydrogel Wound Dressing Advanced Formula for wound management 1 oz.Product did not meet specifications for Zinc Acetate (OOS). | Amerx Health Care Corp. | 05/20/2016Terminated |
| Z-2058-2012 Class II | Oto Ease by Westone, labeled as a bacteria free, greaseless lubricant. Sold in 0.5 oz…Westone is recalling all Oto Ease ear lubricant in all packaging configurations and sizes due to potential… | Westone Laboratories, Inc. | 07/13/2012Terminated |
| Z-2191-2011 | Forteo [teriparatide (rDNA origin) injection] black starter kits containing Triad…Eli Lilly and Company announced 3/17/2011 that patients should not use the alcohol prep pads made by the… | Eli Lilly and Company | 03/17/2011Terminated |
| Z-1968-2011 | Lube Jelly, 1 oz. water-base sterile lubricating jelly, a component of various Presource…The Presource kits were assembled with non-sterile petroleum base lubricant instead of the labeled sterile… | Cardinal Health | 02/28/2011Terminated |
| Z-1897-2011 | Rusch Irrigation Tray w/Bulb Catalogue Number 68895 For irrigation according to…The irrigation trays contain alcohol prep pads which are included in the scope of a recall initiated by… | Teleflex Medical | 02/24/2011Terminated |
| Z-1896-2011 | Rusch Irrigation Tray w/Piston Catalogue Number 67890 For irrigation according to…The irrigation trays contain alcohol prep pads which are included in the scope of a recall initiated by… | Teleflex Medical | 02/24/2011Terminated |
| Z-2013-2011 | Lubricating Jelly packaged as follows: (1) DeRoyal(R) Water Soluble Lubricant, Size: 5…Possible contamination due to sterilization issue. Inspection of contract manufacturer found cGMP… | DeRoyal Processing Center | 02/07/2011Terminated |
| Z-1040-2011 | Irrigation Kit, Small, Vinyl, REF: 6116, Apogee Medical, LLC, 90 Weathers Street…This recall has been initiated due to concerns expressed by the Food and Drug Administration regarding the… | Apogee Medical | 01/18/2011Terminated |
| Z-1039-2011 | Irrigation Kit, Medium, Vinyl, REF: 6115, Apogee Medical, LLC, 90 Weathers Street…This recall has been initiated due to concerns expressed by the Food and Drug Administration regarding the… | Apogee Medical | 01/18/2011Terminated |
| Z-1038-2011 | Irrigation Kit, Large, Vinyl, REF: 6114, Apogee Medical, LLC, 90 Weathers Street…This recall has been initiated due to concerns expressed by the Food and Drug Administration regarding the… | Apogee Medical | 01/18/2011Terminated |
| Z-1037-2011 | Irrigation Kit, Small, Latex, REF: 6113, Apogee Medical, LLC, 90 Weathers Street…This recall has been initiated due to concerns expressed by the Food and Drug Administration regarding the… | Apogee Medical | 01/18/2011Terminated |
| Z-1036-2011 | Irrigation Kit, Medium, Latex, REF: 6112, Apogee Medical, LLC, 90 Weathers Street…This recall has been initiated due to concerns expressed by the Food and Drug Administration regarding the… | Apogee Medical | 01/18/2011Terminated |
| Z-1035-2011 | Irrigation Kit, Large, Latex, REF: 6111, Apogee Medical, LLC, 90 Weathers Street…This recall has been initiated due to concerns expressed by the Food and Drug Administration regarding the… | Apogee Medical | 01/18/2011Terminated |
| Z-1034-2011 | Catheter Insertion Kit, REF: 6100A, Latex Free, Sterile, Apogee Medical, LLC, 90…This recall has been initiated due to concerns expressed by the Food and Drug Administration regarding the… | Apogee Medical | 01/18/2011Terminated |
| Z-0934-2011 | Lubricating Jelly, Sterile, Non-staining, Made in the USA, packaged into the following…Triad Group is recalling all lots of Sterile Lubricating Jelly manufactured by Triad Group. This recall has… | H & P Industries, Inc. dba Triad Group | 12/23/2010Terminated |