Latex Condom with Male Genital Desensitizer Lubricant

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Durex Latex Condom with Male Genital Desensitizer Lubricant

510(k) Number

K020659 ↗

FDA Product Code

HIS

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

• Durex Play Soft & Sensual Lubricant

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• 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

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  FDA 510(k) K032227 Active Cleared 29 Mar 2004

• Durex Play Massage Gel Lubricant

  Class II

  FDA 510(k) K063385 Active Cleared 10 Mar 2008

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• What is the primary purpose of the lubricant included with this condom, and how does it affect the user experience?

  The lubricant in this condom contains a male genital desensitizer, designed to enhance user experience by reducing sensitivity during sexual activity. This feature is intended to complement the condom’s primary function as a mechanical barrier for contraception and sexually transmitted disease prevention, ensuring comfort without compromising protection.

• Is this condom suitable for reuse, or is it intended for single-use only?

  This condom is explicitly designed for single-use only. The packaging is individual, and reuse is not recommended or supported by the manufacturer, as it could compromise barrier integrity and increase the risk of failure.

• What storage conditions are required to maintain the condom’s effectiveness and integrity?

  The condom must be stored in a cool, dry place away from direct sunlight. Avoiding extreme temperatures or moisture ensures the latex remains intact and the lubricant maintains its properties, preserving both protection and usability.

• Are there multiple sizes or models available for this condom, and how would one determine the appropriate fit?

  While the provided data does not specify exact sizes or models, the product is categorized under FDA product code HIS (Condom) and includes multiple registration numbers, suggesting variations may exist. Fit should be determined by standard sizing guidelines (e.g., circumference or length) and user preference, as condoms should snugly cover the erect penis without excessive tightness.

• How does the sterility of this condom impact its use, and what precautions should be taken before application?

  This condom is non-sterile, meaning it is not intended for surgical or invasive procedures. For sexual use, sterility is not a primary concern, but proper hygiene—such as washing hands before use—is recommended to minimize the risk of introducing contaminants. The device is packaged individually to maintain cleanliness until use.