← Back to catalogue

Royal Condoms

FDA 510(k)

Class II (US FDA 510(k))

510(k) K161195

by M3 Global Enterprises, LLC

Identifiers

510(k) Number
K161195 FDA 510(k)
FDA Product Code
HIS FDA 510(k)
Models / Variants
Natural FDA 510(k)
Black Grape FDA 510(k)
Coffee FDA 510(k)
Strawberry FDA 510(k)
and Chocolate Flavors 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 Royal Condoms are a type of condom, classified as a Class II medical device, which acts as a physical barrier to prevent pregnancy and the transmission of sexually transmitted infections. They are available in various flavors, including Natural, Black Grape, Coffee, Strawberry, and Chocolate.

The condoms are supplied for over-the-counter use and are applied to the penis prior to sexual activity. They are regulated under product code HIS and have received FDA 510(k) clearance under approval number K161195.

Frequently asked questions

What are Royal Condoms used for?

Royal Condoms are used as a physical barrier to prevent pregnancy and the transmission of sexually transmitted infections.

Are Royal Condoms available in different flavors?

Yes, Royal Condoms are available in various flavors, including Natural, Black Grape, Coffee, Strawberry, and Chocolate.

How are Royal Condoms supplied?

Royal Condoms are supplied for over-the-counter use and are applied to the penis prior to sexual activity.

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: Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate ..., K161195 FDA 510 (k) - Royal Condoms (Natural, Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
M3 Global Enterprises, LLC

Sources (1)

  • FDA 510(k) K161195 24 fields · synced Oct 6, 2026