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Okamoto 002 Lubricated Polyurethane Male Condom

FDA 510(k)

Class II (US FDA 510(k))

510(k) K203541

by Okamoto Usa, Inc.

Identifiers

510(k) Number
K203541 FDA 510(k)
FDA Product Code
MOL 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 002 Lubricated Polyurethane Male Condom is a synthetic condom used for contraception and prophylactic purposes. It is a medical device classified as a Condom, Synthetic, with a device class of 2. The device is regulated under the regulation number 884.5300 and has a product code of MOL.

The Okamoto 002 Lubricated Polyurethane Male Condom is supplied by Okamoto USA, Inc. and has been cleared under the FDA 510(k) clearance with the number K203541. The device is substantially equivalent and has a traditional clearance type. It is used in the medical specialty of Obstetrics/Gynecology and is reviewed by the Obstetrics/Gynecology advisory committee.

Frequently asked questions

What is the Okamoto 002 Condom made of?

The Okamoto 002 Condom is made of polyurethane, a synthetic material, and is lubricated for ease of use.

What is the intended use of the Okamoto 002 Condom?

The Okamoto 002 Condom is intended for contraception and prophylactic purposes, providing a barrier against pregnancy and disease transmission.

Is the Okamoto 002 Condom regulated by a government agency?

Yes, the Okamoto 002 Condom is regulated under the regulation number 884.5300 and has been cleared under the FDA 510(k) clearance with the number K203541.

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 002 Lubricated Polyurethane Male Condom (K203541) — FDA 510(k ..., K203541 - Okamoto 002 Lubricated Polyurethane Male Condom - FDA 510 (k), Okamoto 002 Lubricated Polyurethane Male Condom… - FDA.report, Okamoto 002 Lubricated Polyurethane Male Condom

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) K203541 24 fields · synced Sep 22, 2026