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510(k) K112110

STERILE LUBRICATING JELLY by Jianerkang Medical Dressing Company — Product Code KMJ

K112110 is an FDA 510(k) premarket notification submitted by Jianerkang Medical Dressing Company for the device "STERILE LUBRICATING JELLY". The FDA issued a decision of Substantially Equivalent on April 10, 2012. The device falls under product code KMJ (Lubricant, Patient), a Class I device regulated under 21 CFR 880.6375.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 2012
Date Received
July 22, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lubricant, Patient
Device Class
Class I
Regulation Number
880.6375
Review Panel
HO
Submission Type

Other clearances for product code KMJ

  • K142473 — Lubricating Jelly (April 13, 2015)
  • K141028 — COLONGLIDE LUBRICANT (July 24, 2014)
  • K131617 — COLONGLIDE(R) LUBRICANT (October 3, 2013)
  • K121390 — LUBE JELLY SURINGE (August 10, 2012)
  • K113689 — DUKAL LUBRICATING JELLY (May 4, 2012)
  • K103718 — DYNACOR LUBRICATION GEL (May 10, 2011)
  • K101522 — ULTRA SEAL STERILE LUBRICATING JELLY (December 23, 2010)
  • K092488 — DYNAREX STERILE LUBRICATING JELLY (December 18, 2009)
  • K083189 — STERI-LUB LUBRICATION GEL (November 21, 2008)
  • K073684 — SHEFFIELD PHARMACEUTICALS (STERILE) LUBRIGEL (May 22, 2008)

FDA data resources