DUREX SPEARMINT SCENTED LUBRICATED LATEX CONDOM (DUREX 'TINGLING PLEASURE' CONDOM— 510(k) K042470

Name: FDA 510(k) clearance K042470
Creator: U.S. Food and Drug Administration
Published: 2005-04-05

Substantially Equivalent

Ssl Americas, Inc.

FDA 510(k) clearance K042470 for DUREX SPEARMINT SCENTED LUBRICATED LATEX CONDOM (DUREX 'TINGLING PLEASURE' CONDOM, Substantially Equivalent on 2005-04-05. Applicant: Ssl Americas, Inc.. Device class: 2.

Clearance details

Applicant: Ssl Americas, Inc.
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 2004-09-13
Decision date: 2005-04-05
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, Inc.

view all

K072169 — DUREX SYNTHETIC POLYISOPRENE MALE CONDOM2008-06-19
K063385 — DUREX PLAY MASSAGE GEL LUBRICANT2008-03-10
K060098 — DUREX PLAY TEMPTATIONS ASSORTED LUBRICANTS2006-06-08
K042958 — DUREX PLAY TINGLING LUBRICANT2005-04-08
K042563 — DUREX PLAY WARMER LUBRICANT2005-02-23

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