Flavored Male Latex Condom

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

510(k) Number

K011253 ↗

FDA Product Code

HIS

Device Class

Class II

Regulation

21 CFR Part 884.5300

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Latex Condom

  Class II

  FDA 510(k) K994095 Active Cleared 18 Jan 2000

• OneTouch Lubricant Gel

  Class II

  FDA 510(k) K142790 Active Cleared 30 Jul 2015

• Thai Nippon Extra Strength Male Latex Condom

  Class II

  FDA 510(k) K032909 Active Cleared 16 Dec 2003

• 'one Touch' Latex Condom with Nonoxynol-9

  Class II

  FDA 510(k) K001978 Active Cleared 8 Aug 2000

• Thai Nippon Male Latex Condom

  Class II

  FDA 510(k) K081265 Active Cleared 16 Oct 2009

• Is this condom sterile, and if not, what does that mean for its use?

  This flavored male latex condom is explicitly labeled as a non-sterile product. Non-sterility means it is not free from all microorganisms, including bacteria and fungi, which could be present on its surface. While this does not preclude its use for contraception or STI prevention, users should follow standard hygiene practices—such as washing hands before and after use—to minimize potential risks. Sterility is not required for barrier contraceptives under FDA regulations for this classification.

• Can this condom be reused, or is it designed for single-use only?

  This condom is intended for single-use only. Latex condoms are not designed to withstand repeated use, as they can degrade over time, compromising their effectiveness in preventing pregnancy or sexually transmitted infections. Reuse may also increase the risk of breakage or failure. Always use a new condom for each sexual encounter.

• What flavors are available for this condom, and how does that affect its use?

  The regulatory data does not specify the exact flavors available for this flavored male latex condom, but the term implies it is designed to enhance user experience with added taste. Flavor does not impact the device’s contraceptive or STI prevention efficacy, as its primary function remains barrier protection. However, flavors may influence user preference or comfort during use.

• Are there different sizes or models available for this condom, and how do I determine the right fit?

  The provided data lists multiple registration numbers (FEI numbers), which typically correspond to different models or variants of the condom, but it does not specify exact sizes (e.g., length, width, or sizing chart). To determine the right fit, users should refer to the manufacturer’s packaging or sizing guidelines, as improper fit can reduce effectiveness or comfort. Since no sizing details are provided in the regulatory summary, contacting the manufacturer directly is recommended for specific model variations.

• How is this condom regulated in the U.S., and what does the FDA’s classification mean for its use?

  This condom is classified as a Class 2 medical device under FDA regulations and has received 510(k) clearance (K011253). This classification means it is subject to general controls (e.g., labeling requirements, manufacturing standards) and special controls specific to barrier contraceptives, including performance testing for effectiveness and safety. The clearance indicates the FDA has determined it is substantially equivalent to a legally marketed predicate device, ensuring it meets applicable regulatory standards for contraception and STI prevention.