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London Royal Consumer Products Latex Condoms

by London International U.S. Holdings, Inc.

510(k) K953813

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 5 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 5 Oct 2026. What this means

Regulatory status

as of registry sync 5 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK953813 Date22 Jul 1996ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 5 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  • Withdrawn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
LTZ
Device Class
Class II
Regulation
21 CFR Part 884.5310
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The London Royal Consumer Products Latex Condoms are classified as a Condom With Nonoxynol-9, a barrier contraceptive device designed to prevent pregnancy and reduce sexually transmitted infection risk. These condoms are made from latex and incorporate nonoxynol-9, a spermicide, to enhance contraceptive effectiveness. They are intended for vaginal use during sexual intercourse and provide a physical barrier to block sperm entry while minimizing exposure to bodily fluids.

These condoms are supplied as single-use, non-sterile products and are regulated under FDA 510(k) clearance (K953813) as a Class II device. They are packaged individually and must be stored in a cool, dry place away from direct sunlight. The product adheres to FDA’s LTZ product code for condoms with nonoxynol-9, with multiple registration numbers (e.g., 3003592318, 3008808138) reflecting compliance with U.S. regulatory requirements. No MRI safety or reusable specifications are applicable.

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