Cleared Abbreviated

K000408 - LIFESTYLES, CONTEMPO OR PRIVATE LABEL STRAWBERRY, VANILLA, OR BANANA FLAVORED CONDOM

K000408 is an FDA 510(k) clearance for LIFESTYLES, manufactured by Suretex Prophylactics , Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Abbreviated 510(k) pathway after a 71-day FDA review.

K000408 · Suretex Prophylactics , Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2000
Decision
71d
Days
Class 2
Risk

K000408 is an FDA 510(k) clearance for the LIFESTYLES, CONTEMPO OR PRIVATE LABEL STRAWBERRY, VANILLA, OR BANANA FLAVORED.... Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Suretex Prophylactics , Ltd. (Dothan, US). The FDA issued a Cleared decision on April 19, 2000 after a review of 71 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.

FDA 510(k) Submission Details - K000408

510(k) Number K000408 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2000
Decision Date April 19, 2000
Days to Decision 71 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
90d faster than avg
Panel avg: 161d · This submission: 71d
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 401
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K000408.
LIFESTYLES, CONTEMPO OR PRIVATE LABEL LARGE CONDOM
K001883 · Ansell Healthcare, Inc. · Jul 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
TROJAN LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT
K000748 · Armkel, LLC · Apr 2000
INVIGRA MALE LATEX CONDOM GREEN COLORED AND MINT FLAVORED
K000038 · Indus Medicare , Ltd. · Mar 2000
INVIGRA MALE LATEX CONDOM YELLOW COLORED AND BANANA FLAVORED
K000039 · Indus Medicare , Ltd. · Mar 2000
K000408 · LIFESTYLES, CONTEMPO OR PRIVATE LABEL STRAWBERRY, VANILLA, OR BANANA FLAVORED CONDOM
Download PDF FDA Summary Suretex Prophylactics…