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Okamoto Studded Condom

FDA 510(k)

Class II (US FDA 510(k))

510(k) K141256

by Okamoto Usa, Inc.

Identifiers

510(k) Number
K141256 FDA 510(k)
FDA Product Code
HIS FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 884.5300 FDA 510(k)
Regulation Number
884.5300 FDA 510(k)
Advisory Committee
Obstetrics/Gynecology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Okamoto Studded Condom is a barrier contraceptive device classified as a condom, designed to cover the penis during sexual intercourse. It is manufactured from natural rubber latex and features a tapered shape, reservoir tip, and an exterior dotted texture formed during molding with an engraved glass mold. This texture enhances tactile sensation while maintaining barrier protection against sexually transmitted infections and unintended pregnancy.

This device is supplied as a single-use, non-sterile product intended for over-the-counter use. It is classified under FDA regulation number 884.5300 and falls under device class II. The product is not intended for MRI use and must be stored in a cool, dry place away from direct sunlight. Authorized by an FDA 510(k) clearance (K141256), it adheres to obstetrics/gynecology standards and is distributed by Okamoto USA, Inc.

Frequently asked questions

What is the Okamoto Studded Condom designed for?

The Okamoto Studded Condom is a barrier contraceptive device designed to cover the penis during sexual intercourse. Its primary purpose is to provide protection against sexually transmitted infections (STIs) and unintended pregnancy. The exterior dotted texture is engineered to enhance tactile sensation during use while maintaining the condom’s barrier function.

How is the Okamoto Studded Condom supplied and intended for use?

This condom is supplied as a single-use product, meaning each unit is intended for one sexual encounter only. It is classified as non-sterile and is intended for over-the-counter use, meaning it can be purchased without a prescription. The product is manufactured from natural rubber latex and is not intended for reuse.

Is the Okamoto Studded Condom sterile? If not, what does that mean for its use?

No, the Okamoto Studded Condom is not sterile. Non-sterile condoms are not treated to eliminate all microorganisms, which means they may contain some bacteria or other microbes. This is generally safe for over-the-counter use as condoms are designed to provide protection against STIs and pregnancy, not to treat or prevent infections caused by microbes present on the condom itself. Sterility is not required for barrier contraceptives like condoms unless they are intended for surgical or invasive procedures.

How should the Okamoto Studded Condom be stored?

The Okamoto Studded Condom should be stored in a cool, dry place away from direct sunlight. Exposure to heat, moisture, or sunlight can degrade the latex material, compromising its integrity and effectiveness. Proper storage ensures the condom remains intact and functional until use.

What are the key features that distinguish the Okamoto Studded Condom from other condoms?

The Okamoto Studded Condom is distinguished by its exterior dotted texture, created during molding with an engraved glass mold. This texture is intended to enhance tactile sensation for the user while maintaining the condom’s barrier properties. Additionally, it features a tapered shape and reservoir tip, which are standard for many condoms but are explicitly mentioned here to highlight its design. The product is also FDA-cleared under the 510(k) pathway, ensuring it meets regulatory standards for safety and effectiveness.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: OKAMOTO STUDDED CONDOM (K141256) — FDA 510 (k) | Innolitics, Okamoto USA, Inc. FDA 510 (k) Products - Latest 2026

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Okamoto Usa, Inc.

Sources (1)

  • FDA 510(k) K141256 24 fields · synced Oct 1, 2026