KMJ · Lubricant, Patient
General Hospital · 21 CFR 880.6375 · Class 1
Overview
| Product Code | KMJ |
|---|---|
| Device Name | Lubricant, Patient |
| Regulation | 21 CFR 880.6375 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
Identification
A patient lubricant is a device intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.
Classification Rationale
Class I (general controls). Except when the device is a vaginal patient lubricant or an oral lubricant, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
Recent Cleared Devices (20 of 49)
Showing 20 most recent of 49 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K142473 | Lubricating Jelly | Sion Biotext Medical , Ltd. | Apr 13, 2015 | SESE |
| K141028 | COLONGLIDE LUBRICANT | Pediatric Pharmaceuticals, Inc. | Jul 24, 2014 | SESE |
| K131617 | COLONGLIDE(R) LUBRICANT | Pediatric Pharmaceuticals, Inc. | Oct 3, 2013 | SESE |
| K121390 | LUBE JELLY SURINGE | Nurse Assist, Inc. | Aug 10, 2012 | SESE |
| K113689 | DUKAL LUBRICATING JELLY | Dukal Corporation | May 4, 2012 | SESE |
| K112110 | STERILE LUBRICATING JELLY | Jianerkang Medical Dressing Company | Apr 10, 2012 | SESE |
| K103718 | DYNACOR LUBRICATION GEL | Medline Industries, Inc. | May 10, 2011 | SESE |
| K101522 | ULTRA SEAL STERILE LUBRICATING JELLY | Ultra Seal Corporation | Dec 23, 2010 | SESE |
| K092488 | DYNAREX STERILE LUBRICATING JELLY | Dynarex Corporation | Dec 18, 2009 | SESE |
| K083189 | STERI-LUB LUBRICATION GEL | Avail Medical Products, Inc. | Nov 21, 2008 | SESE |
| K073684 | SHEFFIELD PHARMACEUTICALS (STERILE) LUBRIGEL | Sheffield Industries, Div. of Faria , Ltd. | May 22, 2008 | SESE |
| K080042 | SPIRUS MEDICAL SURGICAL INSTRUMENT | Spirus Medical, Inc. | Apr 3, 2008 | SESE |
| K042563 | DUREX PLAY WARMER LUBRICANT | Ssl Americas, Inc. | Feb 23, 2005 | SESE |
| K041060 | E-Z LUBRICATING JELLY | Chester Labs, Inc. | May 7, 2004 | SESE |
| K020586 | GOOD LUBRICATIONS | Biofilm, Inc. | Jan 24, 2003 | SESE |
| K974768 | PDI STERILE LUBRICATING JELLY | Nice-Pak Products, Inc. | Jan 16, 1998 | SESE |
| K973557 | LUBRIGLIDE | Qualis, Inc. | Oct 10, 1997 | SESE |
| K961502 | LUBRICATING JELLY, LOW VISCOSITY | Span-America Medical Systems, Inc. | Jul 18, 1996 | SESE |
| K961222 | EVRON GEL | Pharmaceutical Innovations, Inc. | Jun 26, 1996 | SESE |
| K951431 | AQUAGEL LUBRICATING JELLY | Depuy Healthcare | Jul 21, 1995 | SESE |
Top Applicants
- Span-America Medical Systems, Inc. — 3 clearances
- Abco Dealers, Inc. — 2 clearances
- Biofilm, Inc. — 2 clearances
- General Medical Co. — 2 clearances
- Osbon Medical Systems, Ltd. — 2 clearances
