Durex Synthetic Polyisoprene Male Condom

• 2 recalls, same reason

  • Terminated Z-0994-2019 FDA Class II ·initiated 19 Dec 2018
  • Terminated Z-0993-2019 FDA Class II ·initiated 19 Dec 2018

  Five batches of the product have failed the specification of 1.0kPa for Burst Pressure.

• • Terminated Z-0091-2019 FDA Class II ·initiated 6 Aug 2018

  Product marketed in U.S. does not have sufficient data to ensure that it will meet the internal burst pressure specifications at the end of 5 yrs shelf-life

• • Terminated Z-3241-2018 FDA Class II ·initiated 23 Jul 2018

  The products failed the filed specification of 1.0kPa for Burst Pressure.

510(k) Number

K072169 ↗

FDA Product Code

MOL

Device Class

Class II

Regulation

21 CFR Part 884.5300

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Durex Male Colored Latex Condoms with Scented Lubricants

  Class II

  FDA 510(k) K052959 Active Cleared 27 Jan 2006

• Durex Spearmint Scented Lubricated Latex Condom

  Class II

  FDA 510(k) K042470 Active Cleared 5 Apr 2005

• Latex Condom with Male Genital Desensitizer Lubricant

  Class II

  FDA 510(k) K020659 Active Cleared 29 Mar 2002

• Durex Play Soft & Sensual Lubricant

  Class II

  FDA 510(k) K071626 Active Cleared 1 Apr 2008

• Regent Biogel Skinsense Sterile Powder-Free, Synthetic Polyisoprene Surgeon's Glove

  Class I

  FDA 510(k) K020308 Active Cleared 3 Apr 2002

• Durex Flavored Latex Condom

  Class II

  FDA 510(k) K032227 Active Cleared 29 Mar 2004

See all devices from Ssl Americas →