Sterile Lubricating Jelly

FDA 510(k) K112110 · Jianerkang Medical Dressing Company

Substantially Equivalent

510(k) numberK112110

Submission

Device name
Sterile Lubricating Jelly
Applicant
Jianerkang Medical Dressing Company
Jintan City, Jiangsu, CN
Received
July 22, 2011
Decision date
April 10, 2012
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KMJ – Lubricant, Patient
Device class
Class I (low risk)
Regulation
21 CFR 880.6375
Specialty
General Hospital

Other 510(k)s with product code KMJ

510(k)DeviceApplicantDecision
K142473Lubricating JellyKMJ · Traditional Sion Biotext Medical , Ltd.04/13/2015SE
K141028Colonglide LubricantKMJ · Special Pediatric Pharmaceuticals, Inc.07/24/2014SE
K131617Colonglide(R) LubricantKMJ · Traditional Pediatric Pharmaceuticals, Inc.10/03/2013SE
K121390Lube Jelly SuringeKMJ · Traditional Nurse Assist, Inc.08/10/2012SE
K113689Dukal Lubricating JellyKMJ · Traditional Dukal Corporation05/04/2012SE
K103718Dynacor Lubrication GelKMJ · Traditional Medline Industries, Inc.05/10/2011SE
K101522Ultra Seal Sterile Lubricating JellyKMJ · Traditional Ultra Seal Corporation12/23/2010SE
K092488Dynarex Sterile Lubricating JellyKMJ · Traditional Dynarex Corporation12/18/2009SE
K083189Steri-Lub Lubrication GelKMJ · Special Avail Medical Products, Inc.11/21/2008SE
K073684Sheffield Pharmaceuticals (Sterile) LubrigelKMJ · Traditional Sheffield Industries, Div. of Faria , Ltd.05/22/2008SE

Questions and answers

When was Sterile Lubricating Jelly cleared by the FDA?

Sterile Lubricating Jelly (K112110) received a 510(k) decision of Substantially Equivalent on April 10, 2012, 263 days after the submission was received.

What is the product code of K112110?

The FDA product code is KMJ – Lubricant, Patient, a Class I (low risk) device regulated under 21 CFR 880.6375.