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Skinless-Skin Pink Tint Condom

FDA 510(k)

Class II (US FDA 510(k))

510(k) K872812

by Okamoto Usa, Inc.

Identifiers

510(k) Number
K872812 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 Skinless-Skin Pink Tint Condom is a barrier contraceptive device designed for use during sexual activity to prevent pregnancy and reduce the risk of sexually transmitted infections. Manufactured by Okamoto USA, Inc., it is a latex-based product with a pink tint and is intended for single use.

The device is supplied sterile and is intended for single use only. It is not reusable and should be discarded after use. The product is regulated under FDA 510(k) clearance and is classified as a Class II medical device. Proper storage should be maintained in a cool, dry place away from direct sunlight.

Frequently asked questions

What is the Skinless-Skin Pink Tint Condom used for?

This device is a barrier contraceptive intended for use during sexual activity to prevent pregnancy and reduce the risk of sexually transmitted infections.

Is the product sterile and intended for single use?

Yes, the Skinless-Skin Pink Tint Condom is supplied sterile and is intended for single use only; it should not be reused and must be discarded after use.

How should the condom be stored?

To maintain integrity, the product should be stored in a cool, dry place away from direct sunlight.

What is the regulatory status of this device?

The Skinless-Skin Pink Tint Condom is regulated under FDA 510(k) clearance and is classified as a Class II medical device.

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: SKINLESS-SKIN, PINK TINT (CONDOM) (K872812) - Innolitics, FDA Advisory No.2021-1179 || Public Health Warning Against the Purchase ..., Household Products | OKAMOTO INDUSTRIES, INC.

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) K872812 24 fields · synced Sep 25, 2026