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510(k) K974768

PDI STERILE LUBRICATING JELLY by Nice-Pak Products, Inc. — Product Code KMJ

K974768 is an FDA 510(k) premarket notification submitted by Nice-Pak Products, Inc. for the device "PDI STERILE LUBRICATING JELLY". The FDA issued a decision of Substantially Equivalent on January 16, 1998. The device falls under product code KMJ (Lubricant, Patient), a Class I device regulated under 21 CFR 880.6375. Nice-Pak Products, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 1998
Date Received
December 22, 1997
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 by Nice-Pak Products, Inc.

  • K840342 — PDI PREPMASTER WET PACK PATIENT PREP KIT (March 27, 1984)
  • K840343 — PDI PREPMASTER WET PACK VAGINAL-X21477 (March 27, 1984)
  • K840344 — PDI PREPMASTER WET PACK MINOR PROCEDURE (March 26, 1984)
  • K833549 — PDI SURGICAL SCRUB/BRUSH T150-70 (November 28, 1983)
  • K810337 — PDI SURGICAL SCRUB SPONGE-BRUSH-T15070 (February 26, 1981)
  • K781539 — ISO-CARE KIT (November 3, 1978)
  • K780279 — ICE-PAK, PDI (April 10, 1978)
  • K780400 — DEN-Z-ORB (March 27, 1978)

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