Cleared Traditional

K871304 - LIFESTYLES EXTRA STRENGTH CONDOMS W/NON...

K871304 is the FDA 510(k) clearance for LIFESTYLES EXTRA STRENGTH CONDOMS W/NON... by Ansell, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HIS) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K871304 · Ansell, Inc. · Obstetrics & Gynecology device
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Jun 1987
Decision
71d
Days
Class 2
Risk

K871304 is an FDA 510(k) clearance for the LIFESTYLES EXTRA STRENGTH CONDOMS W/NONOXYNOL-9. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Ansell, Inc. (Dothan, US). The FDA issued a Cleared decision on June 11, 1987 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 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, Inc. devices

Submission Details

510(k) Number K871304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1987
Decision Date June 11, 1987
Days to Decision 71 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 160d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.