Cleared Traditional

SKINLESS SKIN-HARMONY CONDOMS

K872664 · Okamoto USA, Inc. · Obstetrics & Gynecology
Nov 1987
Decision
120d
Days
Class 2
Risk

About This 510(k) Submission

K872664 is an FDA 510(k) clearance for the SKINLESS SKIN-HARMONY CONDOMS, a Condom (Class II — Special Controls, product code HIS), submitted by Okamoto USA, Inc. (Stratford, US). The FDA issued a Cleared decision on November 5, 1987, 120 days after receiving the submission on July 8, 1987. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5300.

Submission Details

510(k) Number K872664 FDA.gov
FDA Decision Cleared SESE
Date Received July 08, 1987
Decision Date November 05, 1987
Days to Decision 120 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary —

Device Classification

Product Code HIS — Condom
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.5300

Similar Devices — HIS Condom

All 399
LifeStyles? HydraFeel Natural Rubber Latex Condom
K252521 · Suretex Limited · Nov 2025
Natural rubber latex male condom
K250034 · Shaoguan Regenex Pharmaceuticals Co., Ltd. · Jul 2025
Lelo Hex Lubricated Natural Rubber Latex Condom
K243421 · Lelo, Inc. · Mar 2025
Trojan? Ultra Ribbed Ecstasy latex condom with lubricant (Trojan? Ultra Ribbed Ecstasy)
K243640 · Church & Dwight Co., Inc. · Feb 2025
0.04 ZERO ZERO FOUR Male Latex Condom
K243584 · Okamoto USA, Inc. · Feb 2025
LifeStyles NRL Textured Condom
K232279 · Suretex Limited · Oct 2023