MEGA BIG BOY CONDOM— 510(k) K140379

Substantially Equivalent

Okamoto USA, Inc.

FDA 510(k) clearance K140379 for MEGA BIG BOY CONDOM, Substantially Equivalent on 2014-07-01. Applicant: Okamoto USA, Inc.. Device class: 2.

Clearance details

Applicant: Okamoto USA, Inc.
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 2014-02-14
Decision date: 2014-07-01
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Washington, DC, 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 Okamoto USA, Inc.

K243584 — 0.04 ZERO ZERO FOUR Male Latex Condom2025-02-18
K203541 — Okamoto 002 Lubricated Polyurethane Male Condom2022-02-25
K192669 — Extremely Thin 003, ZERO ZERO THREE2020-07-24
K141256 — OKAMOTO STUDDED CONDOM2014-07-23
K090259 — OKAMOTO ULTRA THIN2009-03-31

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