Cleared Traditional

K001974 - EZ-ON CONDOM

K001974 is an FDA 510(k) clearance for EZ-ON CONDOM, manufactured by Mayer Laboratories. The device is a Class 2 Obstetrics & Gynecology device with product code MOL cleared through the Traditional 510(k) pathway after a 482-day FDA review.

K001974 · Mayer Laboratories · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2001
Decision
482d
Days
Class 2
Risk

K001974 is an FDA 510(k) clearance for the EZ-ON CONDOM. Classified as Condom, Synthetic (product code MOL), Class II - Special Controls.

Submitted by Mayer Laboratories (Oakland, US). The FDA issued a Cleared decision on October 24, 2001 after a review of 482 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5300 - the FDA obstetrics and gynecology 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

FDA 510(k) Submission Details - K001974

510(k) Number K001974 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2000
Decision Date October 24, 2001
Days to Decision 482 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
321d slower than avg
Panel avg: 161d · This submission: 482d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MOL Device Classification - Class 2, Special Controls

Product Code MOL Condom, Synthetic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - MOL Condom, Synthetic

All 21
Devices cleared under the same product code (MOL) and FDA review panel - the closest regulatory comparables to K001974.
DUREX SYNTHETIC POLYISOPRENE MALE CONDOM
K072169 · Ssl Americas, Inc. · Jun 2008
LIFESTYLES LUBRICATED POLYISOPRENE LATEX MALE CONDOM
K070800 · Ansell Healthcare Products, LLC · Mar 2008
TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM
K050828 · Church & Dwight Co., Inc. · Feb 2006
LUBRICATED BAGGY TACTYLON CONDOM
K974121 · Sensicon Corp. · Jan 1998
TACTYLON CONDOM
K971590 · Sensicon Corp. · Oct 1997
SPERM PREPARATION MEDIA
K962816 · Intl., Inc. · Nov 1996
K001974 · EZ-ON CONDOM
Download PDF FDA Summary Mayer Laboratories