Cleared Traditional

K901192 - TROJAN-ENZ LUBRI. CONDOMS (MODIFIED LAB...

K901192 is an FDA 510(k) clearance for TROJAN-ENZ LUBRI. CONDOMS (MODIFIED LAB..., manufactured by Carter Products. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K901192 · Carter Products · Obstetrics & Gynecology device
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Apr 1990
Decision
35d
Days
Class 2
Risk

K901192 is an FDA 510(k) clearance for the TROJAN-ENZ LUBRI. CONDOMS (MODIFIED LABELING). Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Carter Products (Cranbury, US). The FDA issued a Cleared decision on April 16, 1990 after a review of 35 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 Carter Products devices

FDA 510(k) Submission Details - K901192

510(k) Number K901192 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1990
Decision Date April 16, 1990
Days to Decision 35 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
125d faster than avg
Panel avg: 160d · This submission: 35d
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 74
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K901192.
TROJAN NATURALAMB LUBRICATED NATURAL MODIFIED
K901202 · Carter Products · Jun 1990
TROJANS LATEX CONDOMS (MODIFIED LABELING)
K901190 · Carter Products · Apr 1990
TROJAN-ENZ LATEX CONDOMS (MODIFIED LABELING)
K901191 · Carter Products · Apr 1990
TROJAN PLUS LUBRI. LATEX CONDOMS (MODIFIED LABEL)
K901193 · Carter Products · Apr 1990
TROJAN RIBBED LUBRI. LATEX CONDOMS MODIFIED LABEL
K901194 · Carter Products · Apr 1990
TROJAN RIBBED NATURALUBE LUBRI. CONDOMS MODIFIED
K901195 · Carter Products · Apr 1990