Cleared Traditional

STERILE LUBRICATING JELLY

K112110 · Jianerkang Medical Dressing Company · General Hospital
Apr 2012
Decision
263d
Days
Class 1
Risk

About This 510(k) Submission

K112110 is an FDA 510(k) clearance for the STERILE LUBRICATING JELLY, a Lubricant, Patient (Class I — General Controls, product code KMJ), submitted by Jianerkang Medical Dressing Company (Jintan City, Jiangsu, CN). The FDA issued a Cleared decision on April 10, 2012, 263 days after receiving the submission on July 22, 2011. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6375.

Submission Details

510(k) Number K112110 FDA.gov
FDA Decision Cleared SESE
Date Received July 22, 2011
Decision Date April 10, 2012
Days to Decision 263 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code KMJ — Lubricant, Patient
Device Class Class I — General Controls
CFR Regulation 21 CFR 880.6375