Product code KMJ
- Device name
- Lubricant, Patient
- Medical specialty
- General Hospital
- Device class
- 1
- Regulation number
- 880.6375
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K142473 | Lubricating Jelly | Sion Biotext Medical , Ltd. | 2015-04-13 |
| K141028 | COLONGLIDE LUBRICANT | Pediatric Pharmaceuticals, Inc. | 2014-07-24 |
| K131617 | COLONGLIDE(R) LUBRICANT | Pediatric Pharmaceuticals, Inc. | 2013-10-03 |
| K121390 | LUBE JELLY SURINGE | Nurse Assist, Inc. | 2012-08-10 |
| K113689 | DUKAL LUBRICATING JELLY | Dukal Corporation | 2012-05-04 |
| K112110 | STERILE LUBRICATING JELLY | Jianerkang Medical Dressing Company | 2012-04-10 |
| K103718 | DYNACOR LUBRICATION GEL | Medline Industries, Inc. | 2011-05-10 |
| K101522 | ULTRA SEAL STERILE LUBRICATING JELLY | Ultra Seal Corporation | 2010-12-23 |
| K092488 | DYNAREX STERILE LUBRICATING JELLY | Dynarex Corporation | 2009-12-18 |
| K083189 | STERI-LUB LUBRICATION GEL | Avail Medical Products, Inc. | 2008-11-21 |
| K073684 | SHEFFIELD PHARMACEUTICALS (STERILE) LUBRIGEL | Sheffield Industries, Div. of Faria , Ltd. | 2008-05-22 |
| K080042 | SPIRUS MEDICAL SURGICAL INSTRUMENT | Spirus Medical, Inc. | 2008-04-03 |
| K042563 | DUREX PLAY WARMER LUBRICANT | Ssl Americas, Inc. | 2005-02-23 |
| K041060 | E-Z LUBRICATING JELLY | Chester Labs, Inc. | 2004-05-07 |
| K020586 | GOOD LUBRICATIONS | Biofilm, Inc. | 2003-01-24 |
| K974768 | PDI STERILE LUBRICATING JELLY | Nice-Pak Products, Inc. | 1998-01-16 |
| K973557 | LUBRIGLIDE | Qualis, Inc. | 1997-10-10 |
| K961502 | LUBRICATING JELLY, LOW VISCOSITY | Span-America Medical Systems, Inc. | 1996-07-18 |
| K961222 | EVRON GEL | Pharmaceutical Innovations, Inc. | 1996-06-26 |
| K951431 | AQUAGEL LUBRICATING JELLY | Depuy Healthcare | 1995-07-21 |
| K943010 | MAXILUBE | Mission Pharmacal Co. | 1995-07-19 |
| K944969 | STERI-LUB LUBRICATION GEL | Horizon Medical, Inc. | 1995-02-27 |
| K935299 | ASTROGLIDE | Biofilm, Inc. | 1994-02-18 |
| K915574 | COMFORT PERSONAL LUBRICANT | Hyman, Phelps & McNamara, P.C. | 1993-02-19 |
| K912975 | OPERAND LUBRICATING JELLY | General Medical Co. | 1991-09-27 |
| K910790 | MENTOR LUBRICATING JELLY | Mentor Corp. | 1991-05-03 |
| K903910 | LUBRICATING JELLY | Lake Pharmaceutical, Inc. | 1990-10-26 |
| K903717 | DISPENSA-LUBE | Gam-Med Packaging Corp. | 1990-09-06 |
| K900110 | OPERAND* LUBRICATING JELLY | General Medical Co. | 1990-05-02 |
| K895406 | OSBON PERSONAL LUBRICANT | Osbon Medical Systems, Ltd. | 1989-12-01 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08887500730017 | SuperSlyde | ICM PHARMA PTE. LTD. | 2026-04-29 |
| 08887500730024 | SuperSlyde | ICM PHARMA PTE. LTD. | 2026-04-29 |
| 08887500730031 | SuperSlyde | ICM PHARMA PTE. LTD. | 2026-04-29 |
| 30080196074192 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2025-04-25 |
| 14026704921697 | ARROW | TELEFLEX INCORPORATED | 2024-04-08 |
| 10304040165161 | Henry Schein | HENRY SCHEIN, INC. | 2023-07-31 |
| 10304040165154 | Henry Schein | HENRY SCHEIN, INC. | 2023-07-31 |
| 10326053118538 | Regard™ | Resource Optimization & Innovation, L.L.C. | 2023-01-13 |
| 10080196291595 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2022-12-02 |
| 10080196291588 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2022-12-02 |
| M220P9031003 | PRO ADVANTAGE | NATIONAL DISTRIBUTION & CONTRACTING, INC. | 2022-10-16 |
| M220P9032008 | PRO ADVANTAGE | NATIONAL DISTRIBUTION & CONTRACTING, INC. | 2022-10-16 |
| 26921865500062 | EndoGlide+™ | Jianerkang Medical Co., Ltd | 2022-05-18 |
| 26921865500055 | EndoGlide+™ | Jianerkang Medical Co., Ltd | 2022-05-18 |
| 16921865500041 | EndoGlide+™ | Jianerkang Medical Co., Ltd | 2022-05-18 |
| 16921865500034 | EndoGlide+™ | Jianerkang Medical Co., Ltd | 2022-05-18 |
| 10885632104831 | MediChoice | OWENS & MINOR DISTRIBUTION, INC. | 2020-09-22 |
| 10885632104251 | MediChoice | OWENS & MINOR DISTRIBUTION, INC. | 2020-09-22 |
| 10885632104336 | MediChoice | OWENS & MINOR DISTRIBUTION, INC. | 2020-09-22 |
| 10885632104671 | MediChoice | OWENS & MINOR DISTRIBUTION, INC. | 2020-09-22 |
| H65811256801 | Henry Schein | HENRY SCHEIN, INC. | 2019-05-06 |
| H65811256791 | Henry Schein | HENRY SCHEIN, INC. | 2019-05-06 |
| 10885380111419 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2019-04-22 |
| 10885380100697 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2019-04-22 |
| 10885380100338 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2019-04-22 |
| 24026704067620 | RUSCH | TELEFLEX INCORPORATED | 2018-09-15 |
| 10855683006019 | AQUAGEL | PARKER LABORATORIES INC | 2017-07-05 |
| 10885425502295 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2017-06-28 |
| 10885380100321 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2017-04-19 |
| 10887488559490 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2016-07-18 |