Cleared Traditional

K033076 - LIFESTYLES LIQUID PERSONAL LUBRICANT

K033076 is an FDA 510(k) clearance for LIFESTYLES LIQUID PERSONAL LUBRICANT, manufactured by Ansell Healthcare, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K033076 · Ansell Healthcare, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2003
Decision
81d
Days
Class 2
Risk

K033076 is an FDA 510(k) clearance for the LIFESTYLES LIQUID PERSONAL LUBRICANT. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Ansell Healthcare, Inc. (Dothan, US). The FDA issued a Cleared decision on December 19, 2003 after a review of 81 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 Ansell Healthcare, Inc. devices

FDA 510(k) Submission Details - K033076

510(k) Number K033076 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2003
Decision Date December 19, 2003
Days to Decision 81 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 160d · This submission: 81d
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 60
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K033076.
TROJAN THINTENSITY BRAND MALE LATEX CONDOM LUBRICATED WITH ULTRASMOOTH AND WARM SENSATIONS LUBRICANT
K073016 · Church & Dwight Co., Inc. · Nov 2007
TROJAN-ENZ BRAND
K071313 · Church & Dwight Co., Inc. · Oct 2007
TROJAN THINTENSITY BRAND MALE LATEX CONDOM
K071272 · Church & Dwight Co., Inc. · Sep 2007
TROJAN MINT TINGLE BRAND LATEX CONDOMS
K023405 · Armkel, LLC · Dec 2002
TROJAN EXTRA LARGE LATEX CONDOM
K001212 · Armkel, LLC · May 2000
TROJAN LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT
K000748 · Armkel, LLC · Apr 2000