Cleared Traditional

K041060 - E-Z LUBRICATING JELLY

K041060 is an FDA 510(k) clearance for E-Z LUBRICATING JELLY, manufactured by Chester Labs, Inc.. The device is a Class 1 General Hospital device with product code KMJ cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K041060 · Chester Labs, Inc. · General Hospital
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May 2004
Decision
14d
Days
Class 1
Risk

K041060 is an FDA 510(k) clearance for the E-Z LUBRICATING JELLY. Classified as Lubricant, Patient (product code KMJ), Class I - General Controls.

Submitted by Chester Labs, Inc. (Cincinnati, US). The FDA issued a Cleared decision on May 7, 2004 after a review of 14 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6375 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Chester Labs, Inc. devices

FDA 510(k) Submission Details - K041060

510(k) Number K041060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2004
Decision Date May 07, 2004
Days to Decision 14 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 129d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

KMJ Device Classification - Class 1, General Controls

Product Code KMJ Lubricant, Patient
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6375
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KMJ Lubricant, Patient

All 19
Devices cleared under the same product code (KMJ) and FDA review panel - the closest regulatory comparables to K041060.
DYNACOR LUBRICATION GEL
K103718 · Medline Industries, Inc. · May 2011
GOOD LUBRICATIONS
K020586 · Biofilm, Inc. · Jan 2003
PDI STERILE LUBRICATING JELLY
K974768 · Nice-Pak Products, Inc. · Jan 1998
LUBRIGLIDE
K973557 · Qualis, Inc. · Oct 1997
LUBRICATING JELLY, LOW VISCOSITY
K961502 · Span-America Medical Systems, Inc. · Jul 1996
EVRON GEL
K961222 · Pharmaceutical Innovations, Inc. · Jun 1996