Sheer Thin Aromas Red Latex Condom

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

510(k) Number

K010028 ↗

FDA Product Code

HIS

Device Class

Class II

Regulation

21 CFR Part 884.5300

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Divas Dual Pleasure Male Latex Condom

  Class II

  FDA 510(k) K051273 Active Cleared 19 Aug 2005

• Sheer Thin Aromas Blue Latex Condom

  Class II

  FDA 510(k) K004016 Active Cleared 27 Mar 2001

• Sheer Thin Aromas Yellow Latex Condom

  Class II

  FDA 510(k) K004051 Active Cleared 29 Mar 2001

• Sheer Thin Aromas Green Latex Condom

  Class II

  FDA 510(k) K004036 Active Cleared 27 Mar 2001

• What sizes are available for the Sheer Thin Aromas Red Latex Condom, and how are they identified?

  The Sheer Thin Aromas Red Latex Condom is available in multiple sizes, each identified by a unique FEI (Final Establishment Identification) number. These include sizes like 3005203207, 2084177, 3004063764, and many others listed in the specifications. The FEI numbers correspond to different circumferences or lengths, allowing for a range of fit options for users.

• Is the Sheer Thin Aromas Red Latex Condom intended for reuse, or is it designed for single-use only?

  The Sheer Thin Aromas Red Latex Condom is explicitly designed for single-use only. This is a standard practice for latex condoms to ensure effectiveness in preventing pregnancy and sexually transmitted infections, as reuse can compromise the integrity of the barrier.

• How is the Sheer Thin Aromas Red Latex Condom supplied, and is it sterile?

  The Sheer Thin Aromas Red Latex Condom is supplied sterile and packaged individually for each use. Sterility is a critical requirement for barrier contraceptives to prevent contamination and ensure safety before use.

• What regulatory pathway was followed for FDA clearance of this condom, and what does that mean for its safety and effectiveness?

  The Sheer Thin Aromas Red Latex Condom received FDA 510(k) clearance (K010028) under an abbreviated pathway, meaning it was determined to be substantially equivalent to a legally marketed predicate device. This clearance falls under Class II special controls for latex condoms, ensuring compliance with regulatory standards like 21 CFR 884.5300. The review was conducted by the Obstetrics/Gynecology (OB) advisory committee, confirming its safety and performance for preventing pregnancy and reducing sexually transmitted infection risk.