Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart G — General Hospital and Personal Use Miscellaneous Devices](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices) → [21 CFR 880.6375](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/880.6375) → KMJ — Lubricant, Patient # KMJ · Lubricant, Patient _General Hospital · 21 CFR 880.6375 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KMJ ## Overview - **Product Code:** KMJ - **Device Name:** Lubricant, Patient - **Regulation:** [21 CFR 880.6375](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/880.6375) - **Device Class:** 1 - **Review Panel:** [General Hospital](/submissions/HO) ## 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](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KMJ/K142473.md) | Lubricating Jelly | Sion Biotext Medical , Ltd. | Apr 13, 2015 | SESE | | [K141028](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KMJ/K141028.md) | COLONGLIDE LUBRICANT | Pediatric Pharmaceuticals, Inc. | Jul 24, 2014 | SESE | | [K131617](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KMJ/K131617.md) | COLONGLIDE(R) LUBRICANT | Pediatric Pharmaceuticals, Inc. | Oct 3, 2013 | SESE | | [K121390](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KMJ/K121390.md) | LUBE JELLY SURINGE | Nurse Assist, Inc. | Aug 10, 2012 | SESE | | [K113689](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KMJ/K113689.md) | DUKAL LUBRICATING JELLY | Dukal Corporation | May 4, 2012 | SESE | | [K112110](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KMJ/K112110.md) | STERILE LUBRICATING JELLY | Jianerkang Medical Dressing Company | Apr 10, 2012 | SESE | | [K103718](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KMJ/K103718.md) | DYNACOR LUBRICATION GEL | Medline Industries, Inc. | May 10, 2011 | SESE | | [K101522](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KMJ/K101522.md) | ULTRA SEAL STERILE LUBRICATING JELLY | Ultra Seal Corporation | Dec 23, 2010 | SESE | | [K092488](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KMJ/K092488.md) | DYNAREX STERILE LUBRICATING JELLY | Dynarex Corporation | Dec 18, 2009 | SESE | | [K083189](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KMJ/K083189.md) | STERI-LUB LUBRICATION GEL | Avail Medical Products, Inc. | Nov 21, 2008 | SESE | | [K073684](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KMJ/K073684.md) | SHEFFIELD PHARMACEUTICALS (STERILE) LUBRIGEL | Sheffield Industries, Div. of Faria , Ltd. | May 22, 2008 | SESE | | [K080042](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KMJ/K080042.md) | SPIRUS MEDICAL SURGICAL INSTRUMENT | Spirus Medical, Inc. | Apr 3, 2008 | SESE | | [K042563](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KMJ/K042563.md) | DUREX PLAY WARMER LUBRICANT | Ssl Americas, Inc. | Feb 23, 2005 | SESE | | [K041060](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KMJ/K041060.md) | E-Z LUBRICATING JELLY | Chester Labs, Inc. | May 7, 2004 | SESE | | [K020586](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KMJ/K020586.md) | GOOD LUBRICATIONS | Biofilm, Inc. | Jan 24, 2003 | SESE | | [K974768](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KMJ/K974768.md) | PDI STERILE LUBRICATING JELLY | Nice-Pak Products, Inc. | Jan 16, 1998 | SESE | | [K973557](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KMJ/K973557.md) | LUBRIGLIDE | Qualis, Inc. | Oct 10, 1997 | SESE | | [K961502](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KMJ/K961502.md) | LUBRICATING JELLY, LOW VISCOSITY | Span-America Medical Systems, Inc. | Jul 18, 1996 | SESE | | [K961222](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KMJ/K961222.md) | EVRON GEL | Pharmaceutical Innovations, Inc. | Jun 26, 1996 | SESE | | [K951431](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KMJ/K951431.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KMJ](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KMJ) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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