LIFESTYLES ZERO LUBRICATED LATEX CONDOM— 510(k) K120394

Name: FDA 510(k) clearance K120394
Creator: U.S. Food and Drug Administration
Published: 2012-05-08

Substantially Equivalent

Ansell Heathcare Products, LLC

FDA 510(k) clearance K120394 for LIFESTYLES ZERO LUBRICATED LATEX CONDOM, Substantially Equivalent on 2012-05-08. Applicant: Ansell Heathcare Products, LLC. Device class: 2.

Clearance details

Applicant: Ansell Heathcare Products, LLC
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 2012-02-08
Decision date: 2012-05-08
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Dothan, AL, US

Download summary PDF View on FDA.gov ↗

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K250034 — Natural rubber latex male condom2025-07-11
K243421 — Lelo Hex Lubricated Natural Rubber Latex Condom2025-03-07
K243640 — Trojan Ultra Ribbed Ecstasy latex condom with lubricant (Trojan Ultra Ribbed Ecstasy)2025-02-21

Recalls naming K120394

K-number listed on FDA's recall record

Z-0838-2013 — LifeStyles ZERO 10 uber-thin lubricated latex condoms. Mfd. for Ansell Healthcare Products LLC, Dothan, AL 96303. A sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections).Class II·Terminated·Ansell Healthcare Products LLC·20130114

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K120394.

Data sourced from openFDA. This site is unofficial and independent of the FDA.