Cleared Traditional

K980204 - DUREX LATEX CONDOMS

K980204 is an FDA 510(k) clearance for DUREX LATEX CONDOMS, manufactured by London Intl., LLC. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K980204 · London Intl., LLC · Obstetrics & Gynecology device
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Apr 1998
Decision
87d
Days
Class 2
Risk

K980204 is an FDA 510(k) clearance for the DUREX LATEX CONDOMS. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by London Intl., LLC (Dothan, US). The FDA issued a Cleared decision on April 17, 1998 after a review of 87 days - a notably fast clearance cycle.

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: 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 London Intl., LLC devices

FDA 510(k) Submission Details - K980204

510(k) Number K980204 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 1998
Decision Date April 17, 1998
Days to Decision 87 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 160d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HIS Device Classification - Class 2, Special Controls

Product Code HIS Condom
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 - HIS Condom

All 109
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K980204.
JUST BETWEEN US, PERSONAL LUBRICANT & CONDOM
K982673 · Key West Fragrance & Cosmetic · Oct 1998
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DUREX ULTRA COMFORT
K980319 · London Intl., LLC · May 1998
HTL MALE CONDOM
K980019 · Reddy Medtech Health Products , Ltd. · Apr 1998
WORLDS BEST BRAND NON-LUBRICATED, WORLDS BEST BRAND LUBRICATED
K971028 · Worlds-Best Gummivarefabrik A/S · Mar 1998
LATEX CONDOMS NATURAL COLOUR WITH SILICONE OIL LUBRICANT
K974323 · Reddy Medtech Health Products , Ltd. · Feb 1998