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Lubricated Condom

by Royal American Industries, Inc.

510(k) K872504

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK872504 Date20 Nov 1987ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

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

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Lubricated Condom is a device classified under the medical specialty of Obstetrics and Gynecology. It is designed to function as a barrier device.

This device has received FDA 510(k) clearance. It is manufactured by Royal American Industries, Inc.

Other devices from Royal American Industries, Inc.

Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary function of the Lubricated Condom?

    The Lubricated Condom is designed to function as a barrier device. It is classified under the medical specialty of Obstetrics and Gynecology.

  • Who is the manufacturer of this device?

    This device is manufactured by Royal American Industries, Inc., located in Boca Raton, Florida.

  • Has this device been reviewed by the FDA?

    Yes, the Lubricated Condom has received FDA 510(k) clearance. The submission was processed under the Obstetrics and Gynecology advisory committee.