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Non-Spermicidal Lubricated Male Latex Condom

by Secure Scientific Sdn Bhd

510(k) K023128

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 · Abbreviated NumberK023128 Date22 Jan 2003ClearedStatusActive

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  • Withdrawn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, 6 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 non-spermicidal lubricated male latex condom is a physical barrier device worn by males during intercourse. It is designed to provide mechanical protection for the purpose of contraception and the prevention of sexually transmitted diseases.

This device is intended for patient self-use in home or private settings. It is regulated as a Class II medical device under FDA 510(k) authorization.

Questions

AI-generated answers, 6 Oct 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 intended use of this lubricated male latex condom?

    This device is a physical barrier designed for male use during intercourse to provide mechanical protection for the purpose of contraception and the prevention of sexually transmitted diseases.

  • In what settings can this device be used?

    This device is intended for patient self-use in home or private settings, allowing for convenient and personal application by the user.

  • What is the regulatory status of this condom?

    This product is regulated as a Class II medical device under FDA 510(k) authorization, which confirms it has been reviewed and found to be substantially equivalent to legally marketed predicate devices.