Cleared Traditional

K991892 - TRUSTEX MINT FLAVORED CONDOM IN GREEN COLOR, IMPULSE MINT FLAVORED CONDOM IN GREEN COLOR

K991892 is an FDA 510(k) clearance for TRUSTEX MINT FLAVORED CONDOM IN GREEN COLOR, manufactured by Line One Laboratories. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K991892 · Line One Laboratories · Obstetrics & Gynecology device
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Aug 1999
Decision
77d
Days
Class 2
Risk

K991892 is an FDA 510(k) clearance for the TRUSTEX MINT FLAVORED CONDOM IN GREEN COLOR, IMPULSE MINT FLAVORED CONDOM IN .... Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Line One Laboratories (Los Angeles, US). The FDA issued a Cleared decision on August 19, 1999 after a review of 77 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.

FDA 510(k) Submission Details - K991892

510(k) Number K991892 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1999
Decision Date August 19, 1999
Days to Decision 77 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
84d faster than avg
Panel avg: 161d · This submission: 77d
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 316
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K991892.
LATEX CONDOM
K994095 · Thai Nippon Rubber Industry Co., Ltd. · Jan 2000
INVIGRA
K993693 · Indus Medicare , Ltd. · Dec 1999
ALATECH LATEX CONDOM
K993887 · Alatech Healthcare, LLC · Dec 1999
VARIOUS ANSELL TRADENAMES OR PRIVATE LABEL
K992081 · Suretex Prophylactics (India) , Ltd. · Aug 1999
ANSELL CONDOMS
K984392 · Ansell, Inc. · Jul 1999
SUMMER'S EVE LUBRICATING JELLY
K990597 · C.B. Fleet Co., Inc. · Jul 1999
K991892 · TRUSTEX MINT FLAVORED CONDOM IN GREEN COLOR, IMPULSE MINT FLAVORED CONDOM IN GREEN COLOR
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