Cleared Traditional

K984392 - ANSELL CONDOMS

K984392 is an FDA 510(k) clearance for ANSELL CONDOMS, manufactured by Ansell, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Traditional 510(k) pathway after a 225-day FDA review.

K984392 · Ansell, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
225d
Days
Class 2
Risk

K984392 is an FDA 510(k) clearance for the ANSELL CONDOMS. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Ansell, Inc. (Dothan, US). The FDA issued a Cleared decision on July 21, 1999 after a review of 225 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 Ansell, Inc. devices

FDA 510(k) Submission Details - K984392

510(k) Number K984392 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1998
Decision Date July 21, 1999
Days to Decision 225 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
65d slower than avg
Panel avg: 160d · This submission: 225d
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 196
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K984392.
ALATECH LATEX CONDOM
K993887 · Alatech Healthcare, LLC · Dec 1999
TRUSTEX MINT FLAVORED CONDOM IN GREEN COLOR, IMPULSE MINT FLAVORED CONDOM IN GREEN COLOR
K991892 · Line One Laboratories · Aug 1999
VARIOUS ANSELL TRADENAMES OR PRIVATE LABEL
K992081 · Suretex Prophylactics (India) , Ltd. · Aug 1999
SUMMER'S EVE LUBRICATING JELLY
K990597 · C.B. Fleet Co., Inc. · Jul 1999
LIFESTYLES XTRA PLEASURE
K983518 · Ansell, Inc. · Jul 1999
MALE NATURAL RUBBER LATEX CONDOM (WITH LUBRICATION)
K990925 · Hardcover Products, Inc. · Jun 1999