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510(k) K041060

E-Z LUBRICATING JELLY by Chester Labs, Inc. — Product Code KMJ

K041060 is an FDA 510(k) premarket notification submitted by Chester Labs, Inc. for the device "E-Z LUBRICATING JELLY". The FDA issued a decision of Substantially Equivalent on May 7, 2004. The device falls under product code KMJ (Lubricant, Patient), a Class I device regulated under 21 CFR 880.6375. Chester Labs, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 2004
Date Received
April 23, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

Other clearances by Chester Labs, Inc.

  • K001705 — STATSIGN ELECTRODE CONDUCTIVITY GEL, GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL, MO (June 29, 2000)
  • K001593 — MODIFICATION TO STATSIGN SALINE ELECTROLYTE GEL, GRAHAM-FIELD SALINE ELECTROLYTE (June 14, 2000)
  • K944598 — GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL (May 7, 1996)
  • K944599 — GRAHAM-FIELD CONDUCTIVE ECG SPRAY (May 7, 1996)
  • K944600 — GRAHAM-FIELD SALINE ELECTROLYTE GEL (November 20, 1995)
  • K944597 — GRAHAM-FIELD ULTRASOUND SCANNING GEL (June 21, 1995)
  • K944596 — GRAHAM-FIELD ULTRASOUND LOTION (June 7, 1995)
  • K940254 — BIOSHIELD BLUE POWDER FREE GLOVE (March 23, 1994)
  • K940256 — BIOSHIELD BLUE LATEX GLOVES (March 23, 1994)
  • K841871 — LIQUA-SONIC GEL (March 14, 1985)

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)
  • K112110 — STERILE LUBRICATING JELLY (April 10, 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)

FDA data resources