Cleared Abbreviated

K001883 - LIFESTYLES, CONTEMPO OR PRIVATE LABEL LARGE CONDOM

K001883 is an FDA 510(k) clearance for LIFESTYLES, manufactured by Ansell Healthcare, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Abbreviated 510(k) pathway after a 40-day FDA review.

K001883 · Ansell Healthcare, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2000
Decision
40d
Days
Class 2
Risk

K001883 is an FDA 510(k) clearance for the LIFESTYLES, CONTEMPO OR PRIVATE LABEL LARGE CONDOM. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Ansell Healthcare, Inc. (Dothan, US). The FDA issued a Cleared decision on July 31, 2000 after a review of 40 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Ansell Healthcare, Inc. devices

FDA 510(k) Submission Details - K001883

510(k) Number K001883 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2000
Decision Date July 31, 2000
Days to Decision 40 days
Submission Type Abbreviated
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
121d faster than avg
Panel avg: 161d · This submission: 40d
Pathway characteristics
Standards-based clearance path.

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 255
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K001883.
REMED MALE TUTTI FRUTTI CONDOM (STRAWBERRY) PREVENTOR, LUCKY BOY, SUMMIT
K993403 · Remed Pharma · Aug 2000
REMED MALE TUTTI FRUTTI CONDOM (COCONUT) PREVENTOR, LUCKY BOY, SUMMIT
K993409 · Remed Pharma · Aug 2000
OSMANTHUS, KONGFU, AND GOBON, NATURAL RUBBER LATEX CONDOMS
K994118 · Guilin Latex Factory · Aug 2000
MALE LATEX COMDOM WITH DOTTED SURFACE
K001221 · Pleasure Latex Products Sdn. Bhd. · May 2000
TROJAN EXTRA LARGE LATEX CONDOM
K001212 · Armkel, LLC · May 2000
LIFESTYLES, CONTEMPO OR PRIVATE LABEL STRAWBERRY, VANILLA, OR BANANA FLAVORED CONDOM
K000408 · Suretex Prophylactics , Ltd. · Apr 2000