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.

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
Combination Product No
PCCP Authorized No
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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KMJ Lubricant, Patient

All 44
Devices cleared under the same product code (KMJ) and FDA review panel - the closest regulatory comparables to K041060.
SHEFFIELD PHARMACEUTICALS (STERILE) LUBRIGEL
K073684 · Sheffield Industries, Div. of Faria , Ltd. · May 2008
SPIRUS MEDICAL SURGICAL INSTRUMENT
K080042 · Spirus Medical, Inc. · Apr 2008
DUREX PLAY WARMER LUBRICANT
K042563 · Ssl Americas, Inc. · Feb 2005
GOOD LUBRICATIONS
K020586 · Biofilm, Inc. · Jan 2003
PDI STERILE LUBRICATING JELLY
K974768 · Nice-Pak Products, Inc. · Jan 1998
LUBRIGLIDE
K973557 · Qualis, Inc. · Oct 1997

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K041060 · E-Z LUBRICATING JELLY
Download PDF Chester Labs, Inc.