Trojan Extra Large Latex Condom

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K001212 ↗

FDA Product Code

HIS

Device Class

Class II

Regulation

21 CFR Part 884.5300

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Positive & Negative Hcg Urine Controls

  Class I

  FDA 510(k) K821742 Active Cleared 2 Jul 1982

• Bactogen-H. Influenzae Type B

  Class II

  FDA 510(k) K800493 Active Cleared 4 Apr 1980

• Bactigen(R) Group B Streptococcus Test

  Class I

  FDA 510(k) K885003 Active Cleared 7 Feb 1989

• Trojan Naturalamb Natural Membrane Condom W/Sperm.

  Class II

  FDA 510(k) K902305 Active Cleared 29 Mar 1991

• Bactigen Group B Streptococcus Test

  Class I

  FDA 510(k) K850772 Active Cleared 29 May 1985

• Brand Name 1-Step Pregnancy Test-May Be Marketed Under First Response, Answer, or Other Brand Names

  Class II

  FDA 510(k) K962183 Active Cleared 10 Jul 1996

See all devices from Armkel, LLC →

• What is the intended use of the Trojan Extra Large Latex Condom?

  This device is a sheath intended for medical purposes to be worn over the male penis during intercourse. It functions as a physical barrier to help prevent pregnancy and the transmission of sexually transmitted diseases.

• What is the regulatory status of this device?

  The Trojan Extra Large Latex Condom is regulated under FDA 510(k) clearance number K001212. It is classified within the Obstetrics and Gynecology medical specialty under regulation number 884.5300.

• Who is the manufacturer of this condom?

  This device is manufactured by Armkel, LLC, located in Cranbury, New Jersey.