Pleasure Plus

FDA 510(k) K902772 · Medimix Products, Inc.

Substantially Equivalent

510(k) numberK902772

Submission

Device name
Pleasure Plus
Applicant
Medimix Products, Inc.
Washington, DC, US
Received
June 22, 1990
Decision date
August 14, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HIS – Condom
Device class
Class II (moderate risk)
Regulation
21 CFR 884.5300
Specialty
Obstetrics/Gynecology

Other 510(k)s with product code HIS

510(k)DeviceApplicantDecision
K252622Male Latex Condom HAHIS · Abbreviated Okamoto USA, Inc.05/04/2026SE
K252521LifeStyles® HydraFeel Natural Rubber Latex CondomHIS · Abbreviated Suretex Limited11/18/2025SE
K250034Natural rubber latex male condomHIS · Traditional Shaoguan Regenex Pharmaceuticals Co., Ltd.07/11/2025SE
K243421Lelo Hex Lubricated Natural Rubber Latex CondomHIS · Traditional Lelo, Inc.03/07/2025SE
K243640Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed Ecstasy)HIS · Traditional Church & Dwight Co., Inc.02/21/2025SE
K2435840.04 ZERO ZERO FOUR Male Latex CondomHIS · Abbreviated Okamoto USA, Inc.02/18/2025SE
K232279LifeStyles NRL Textured CondomHIS · Abbreviated Suretex Limited10/05/2023SE
K230049SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots…HIS · Traditional Ttk Healthcare Limited09/07/2023SE
K222611Male Latex CondomsHIS · Traditional Suzhou Colour-Way New Material Co., Ltd.11/28/2022SE
K220489Durex Patronus CloseFit, Durex Patronus RegularHIS · Traditional Rb Health (Us), LLC11/07/2022SE

More from Rb Health (Us), LLC

510(k)DeviceDecision
K914733TTL Medicated DressingKGX · Traditional 07/01/1992SE
K910664Mod. Trochanter Screw & Washer W/ Anodized Titan.LWJ · Traditional 04/01/1992SE
K860113Double-Ject Transfer NeedleLHI · Traditional 02/12/1986SE

Questions and answers

When was Pleasure Plus cleared by the FDA?

Pleasure Plus (K902772) received a 510(k) decision of Substantially Equivalent on August 14, 1991, 418 days after the submission was received.

What is the product code of K902772?

The FDA product code is HIS – Condom, a Class II (moderate risk) device regulated under 21 CFR 884.5300.