DUREX MALE COLORED LATEX CONDOMS WITH SCENTED LUBRICANTS— 510(k) K052959

Name: FDA 510(k) clearance K052959
Creator: U.S. Food and Drug Administration
Published: 2006-01-27

Substantially Equivalent

Ssl Americas

FDA 510(k) clearance K052959 for DUREX MALE COLORED LATEX CONDOMS WITH SCENTED LUBRICANTS, Substantially Equivalent on 2006-01-27. Applicant: Ssl Americas. Device class: 2.

Clearance details

Applicant: Ssl Americas
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 2005-10-21
Decision date: 2006-01-27
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Norcross, GA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HIS

view all

K252622 — Male Latex Condom HA2026-05-04
K252521 — LifeStyles® HydraFeel Natural Rubber Latex Condom2025-11-18
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

More clearances from Ssl Americas

view all

K072236 — DUREX PLAY TINGLING AQUEOUS BASED LUBRICANT2008-05-07
K071626 — DUREX PLAY SOFT & SENSUAL LUBRICANT2008-04-01
K042957 — DUREX MALE LATEX CONDOM WITH WARMING LUBRICANT2005-02-17
K040185 — DUREX STUDDED/RIBBED LUBRICATED LATEX CONDOM2004-04-27

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