Cleared Traditional

K904000 - TROJAN(R) EXTRA STR LATEX CONDOM W/SPERM SILI LUBR

K904000 is an FDA 510(k) clearance for TROJAN EXTRA STR LATEX CONDOM W/SPERM S..., manufactured by Armkel, LLC. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K904000 · Armkel, LLC · Obstetrics & Gynecology device
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Feb 1991
Decision
174d
Days
Class 2
Risk

K904000 is an FDA 510(k) clearance for the TROJAN(R) EXTRA STR LATEX CONDOM W/SPERM SILI LUBR. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Armkel, LLC (Cranbury, US). The FDA issued a Cleared decision on February 19, 1991 after a review of 174 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Armkel, LLC devices

FDA 510(k) Submission Details - K904000

510(k) Number K904000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1990
Decision Date February 19, 1991
Days to Decision 174 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 160d · This submission: 174d
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 189
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K904000.
TROJAN (TM-TBD) CONDOM
K912901 · Carter Products · Feb 1992
MCLAUGHLIN LAPAROSCOPIC GRASPER
K910578 · Marlo Surgical Technology · Apr 1991
TROJAN NATURALAMB NATURAL MEMBRANE CONDOM W/SPERM.
K902305 · Armkel, LLC · Mar 1991
CONDOM (RUBBER) CONTRACEPTIVE
K905279 · Aladan Corp. · Feb 1991
TROJAN NATURALAMB LUBRICATED NATURAL MODIFIED
K901202 · Carter Products · Jun 1990
CONDOM (RUBBER) CONTRACEPTIVE
K901416 · Aladan Corp. · Jun 1990