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Black Coloured Condom

by Karex Industries Sdn. Bhd. 510(k)

Active United States

510(k) K132597

Overview

The Black Coloured Condom is a barrier contraceptive device classified as a condom, designed to prevent pregnancy and reduce the risk of sexually transmitted infections during sexual intercourse. It functions as a physical barrier between partners, blocking sperm from entering the vagina and preventing the exchange of bodily fluids.

This device is supplied as a single-use, non-sterile product and is regulated under FDA 510(k) clearance with the classification code HIS (Human Intrument). It is intended for use in obstetrics and gynecology settings, adhering to the regulatory requirements outlined in 21 CFR 884.5300. The product is manufactured by Karex Industries Sdn. Bhd. and is distributed with the K-number K132597.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Abbreviated NumberK132597 Date25 Nov 2013ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

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

From the manufacturer

Karex, World's Largest Condom Maker, is a listed company on the Main Market of Bursa Malaysia Securities Berhad.

Source: karex.com.my

KAREX INDUSTRIES SDN. BHD. Pontian, Malaysia Karex Industries Sdn Bhd (KISB) was incorporated in Malaysia under the name of Banrub Sdn Bhd as a private limited company under the Act on 4 May 1988 and commenced operations in 1989. KISB assumed its present name on 5 February 1994 and is principally involved in the manufacturing and sale of condoms.

Source: karex.com.my

Other devices from Karex Industries Sdn. Bhd.

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Questions

  • What is the Black Coloured Condom used for?

    The Black Coloured Condom is a barrier contraceptive device designed to prevent pregnancy and reduce the risk of sexually transmitted infections during sexual intercourse by functioning as a physical barrier between partners.

  • Is the Black Coloured Condom sterile and single-use?

    The Black Coloured Condom is supplied as a single-use, non-sterile product. It is designed for one-time use only and should not be reused to maintain effectiveness and safety.

  • What is the regulatory status of the Black Coloured Condom?

    This device is regulated under FDA 510(k) clearance with the classification code HIS (Human Instrument) and K-number K132597, adhering to regulatory requirements outlined in 21 CFR 884.5300.

  • Who manufactures the Black Coloured Condom?

    The Black Coloured Condom is manufactured by Karex Industries Sdn. Bhd., a company that produces this contraceptive device for use in obstetrics and gynecology settings.