DUREX LATEX CONDOMS— 510(k) K980204

Substantially Equivalent

London Intl., LLC

FDA 510(k) clearance K980204 for DUREX LATEX CONDOMS, Substantially Equivalent on 1998-04-17. Applicant: London Intl., LLC. Device class: 2.

Clearance details

Applicant: London Intl., LLC
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 1998-01-20
Decision date: 1998-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dothan, AL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HIS

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 London Intl., LLC

K982924 — DUREX SENSIDOM LATEX CONDOM1998-11-16
K983380 — DUREX LUBRAGEL LATEX CONDOM1998-11-16
K980174 — DUREX COLORS AND SCENTS1998-08-13
K980785 — STERILE, POWDERFREE LATEX EXAMINATION GLOVE1998-06-10
K980319 — DUREX ULTRA COMFORT1998-05-20

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