Product Code: KMJ FDA class 1 21 CFR 880.6375

Lubricant, Patient

General Hospital

Patient Lubricant is a medical-grade topical lubricant used in clinical settings to facilitate the insertion or passage of medical devices such as catheters, specula, and endoscopes, reducing friction and patient discomfort during procedures. It is classified as FDA Class 1, indicating low risk subject to general controls only, with no premarket clearance required. The product code is KMJ and the applicable regulation is 21 CFR 880.6375 in the General Hospital specialty.

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510(k)s

FEI Numbers

115

Registration Numbers

115

Unique Applicants

Years Active

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Basic Information

Product Code: KMJ
Device Class: FDA class 1
Regulation Number: 880.6375
Medical Specialty: General Hospital
Review Panel: HO
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 49 510(k) clearances via K numbers.

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