Male Latex Condoms

FDA 510(k) K222611 · Suzhou Colour-Way New Material Co., Ltd.

Substantially Equivalent

510(k) numberK222611

Submission

Device name
Male Latex Condoms
Applicant
Suzhou Colour-Way New Material Co., Ltd.
Suzhou, CN
Received
August 30, 2022
Decision date
November 28, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

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
K220489Durex Patronus CloseFit, Durex Patronus RegularHIS · Traditional Rb Health (Us), LLC11/07/2022SE
K222068Durex Penck III RegularHIS · Traditional Rb Health (Us), LLC10/12/2022SE

More from Rb Health (Us), LLC

510(k)DeviceDecision
K240790Polyisoprene Surgical glovesKGO · Traditional 08/23/2024SE
K222620Sterilized Latex Surgical GlovesKGO · Traditional 03/23/2023SE

Questions and answers

When was Male Latex Condoms cleared by the FDA?

Male Latex Condoms (K222611) received a 510(k) decision of Substantially Equivalent on November 28, 2022, 90 days after the submission was received.

What is the product code of K222611?

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