FDA Product Code
FDA Product Code KMJ — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.6375
510(k) Clearances — 49 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K142473 | Lubricating Jelly | Sion Biotext Medical , Ltd. | 2015-04-13 | Traditional | PDF ↗ |
| K141028 | COLONGLIDE LUBRICANT | Pediatric Pharmaceuticals, Inc. | 2014-07-24 | Special | PDF ↗ |
| K131617 | COLONGLIDE(R) LUBRICANT | Pediatric Pharmaceuticals, Inc. | 2013-10-03 | Traditional | PDF ↗ |
| K121390 | LUBE JELLY SURINGE | Nurse Assist, Inc. | 2012-08-10 | Traditional | PDF ↗ |
| K113689 | DUKAL LUBRICATING JELLY | Dukal Corporation | 2012-05-04 | Traditional | PDF ↗ |
| K112110 | STERILE LUBRICATING JELLY | Jianerkang Medical Dressing Company | 2012-04-10 | Traditional | PDF ↗ |
| K103718 | DYNACOR LUBRICATION GEL | Medline Industries, Inc. | 2011-05-10 | Traditional | PDF ↗ |
| K101522 | ULTRA SEAL STERILE LUBRICATING JELLY | Ultra Seal Corporation | 2010-12-23 | Traditional | PDF ↗ |
| K092488 | DYNAREX STERILE LUBRICATING JELLY | Dynarex Corporation | 2009-12-18 | Traditional | PDF ↗ |
| K083189 | STERI-LUB LUBRICATION GEL | Avail Medical Products, Inc. | 2008-11-21 | Special | PDF ↗ |
| K073684 | SHEFFIELD PHARMACEUTICALS (STERILE) LUBRIGEL | Sheffield Industries, Div. of Faria , Ltd. | 2008-05-22 | Traditional | PDF ↗ |
| K080042 | SPIRUS MEDICAL SURGICAL INSTRUMENT | Spirus Medical, Inc. | 2008-04-03 | Traditional | PDF ↗ |
| K042563 | DUREX PLAY WARMER LUBRICANT | Ssl Americas, Inc. | 2005-02-23 | Traditional | PDF ↗ |
| K041060 | E-Z LUBRICATING JELLY | Chester Labs, Inc. | 2004-05-07 | Traditional | PDF ↗ |
| K020586 | GOOD LUBRICATIONS | Biofilm, Inc. | 2003-01-24 | Traditional | PDF ↗ |
| K974768 | PDI STERILE LUBRICATING JELLY | Nice-Pak Products, Inc. | 1998-01-16 | Traditional | PDF ↗ |
| K973557 | LUBRIGLIDE | Qualis, Inc. | 1997-10-10 | Traditional | PDF ↗ |
| K961502 | LUBRICATING JELLY, LOW VISCOSITY | Span-America Medical Systems, Inc. | 1996-07-18 | Traditional | PDF ↗ |
| K961222 | EVRON GEL | Pharmaceutical Innovations, Inc. | 1996-06-26 | Traditional | PDF ↗ |
| K951431 | AQUAGEL LUBRICATING JELLY | Depuy Healthcare | 1995-07-21 | Traditional | PDF ↗ |
| K943010 | MAXILUBE | Mission Pharmacal Co. | 1995-07-19 | Traditional | PDF ↗ |
| K944969 | STERI-LUB LUBRICATION GEL | Horizon Medical, Inc. | 1995-02-27 | Traditional | PDF ↗ |
| K935299 | ASTROGLIDE | Biofilm, Inc. | 1994-02-18 | Traditional | PDF ↗ |
| K915574 | COMFORT PERSONAL LUBRICANT | Hyman, Phelps & McNamara, P.C. | 1993-02-19 | Traditional | PDF ↗ |
| K912975 | OPERAND LUBRICATING JELLY | General Medical Co. | 1991-09-27 | Traditional | PDF ↗ |
| K910790 | MENTOR LUBRICATING JELLY | Mentor Corp. | 1991-05-03 | Traditional | PDF ↗ |
| K903910 | LUBRICATING JELLY | Lake Pharmaceutical, Inc. | 1990-10-26 | Traditional | PDF ↗ |
| K903717 | DISPENSA-LUBE | Gam-Med Packaging Corp. | 1990-09-06 | Traditional | PDF ↗ |
| K900110 | OPERAND* LUBRICATING JELLY | General Medical Co. | 1990-05-02 | Traditional | PDF ↗ |
| K896207 | OSBON PERSONAL LUBRICANT | Osbon Medical Systems, Ltd. | 1989-12-01 | Traditional | PDF ↗ |
| K895406 | OSBON PERSONAL LUBRICANT | Osbon Medical Systems, Ltd. | 1989-12-01 | Traditional | PDF ↗ |
| K882506 | MODIFIED AMERICAN LUBRICATING JELLY, 2.7 & 5.0 | Span-America Medical Systems, Inc. | 1988-09-09 | Traditional | PDF ↗ |
| K881338 | CONDOM-MATE VAGINAL LUBRICANT | Upsher-Smith Laboratories, Inc. | 1988-05-16 | Traditional | PDF ↗ |
| K872128 | K-GEL | Taro Pharmaceuticals, Inc. | 1987-06-12 | Traditional | PDF ↗ |
| K870742 | AMERICAN LUBRICATING JELLY STERILE 2.7G & 5G | Span-America Medical Systems, Inc. | 1987-06-05 | Traditional | PDF ↗ |
| K871169 | LUBRICATING JELLY | H & P Industries, Inc. | 1987-04-01 | Traditional | PDF ↗ |
| K864556 | AQUALUBE(TM) | Parker Laboratories, Inc. | 1986-12-01 | Traditional | PDF ↗ |
| K854155 | STERILE SALINE SOLUTION | I M, Inc. | 1985-12-10 | Traditional | PDF ↗ |
| K853653 | SANA-LUBE | Huntington Laboratories, Inc. | 1985-11-13 | Traditional | PDF ↗ |
| K851617 | TODAY PERSONAL LUBRICANT | Vli Corp. | 1985-06-06 | Traditional | PDF ↗ |
| K822143 | TOMAC LUBRICATING JELLY | American Medical Systems, Inc. | 1982-07-30 | Traditional | PDF ↗ |
| K820587 | WET PACK LINE OF PRODUCTS | Abco Dealers, Inc. | 1982-03-26 | Traditional | PDF ↗ |
| K812297 | A.D.T. PROCEDURES TRAY | A.D.T. Lab Industries | 1981-09-28 | Traditional | PDF ↗ |
| K810049 | PEDICAT* | Pollak (Intl.), Ltd. | 1981-04-21 | Traditional | PDF ↗ |
| K810310 | K-Y LUBRICATING JELLY | Johnson & Johnson Professionals, Inc. | 1981-04-21 | Traditional | PDF ↗ |
| K791970 | HYGENIC RUBBER DAM LUBRICANT | The Hygenic Corp. | 1979-11-16 | Traditional | PDF ↗ |
| K791243 | LUBRICATING JELLY | Abco Dealers, Inc. | 1979-08-03 | Traditional | PDF ↗ |
| K790087 | LUBRICANT, OTRHO PERSONAL | Ortho Pharmaceutical Corp. | 1979-02-01 | Traditional | PDF ↗ |
| K770498 | PRESERVE LUBRICANT CODE NO. 43=4035 | Codman & Shurtleff, Inc. | 1977-06-20 | Traditional | PDF ↗ |
Product code KMJ · Class I · General Hospital. Data: openFDA.