Ansell Condoms

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K984392 ↗

FDA Product Code

HIS

Device Class

Class II

Regulation

21 CFR Part 884.5300

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Nuda-Plus Condom W/Spermicidal Lubricant

  Class II

  FDA 510(k) K822792 Active Cleared 30 Sep 1982

• Condom

  Class II

  FDA 510(k) K940045 Active Cleared 30 Jan 1995

• Patient Examination Gloves (Latex)

  Class I

  FDA 510(k) K892289 Active Cleared 23 Jun 1989

• Derma Prene

  Class I

  FDA 510(k) K820665 Active Cleared 3 May 1982

• G.S.A. Colored Condoms

  Class II

  FDA 510(k) K901112 Active Cleared 27 Mar 1990

• Ansell Conform Green Examination Gloves

  Class I

  FDA 510(k) K897081 Active Cleared 26 Mar 1990

See all devices from Ansell, Inc. →