Choice Also Kondum

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

510(k) Number

K880919 ↗

FDA Product Code

HIS

Device Class

Class II

Regulation

21 CFR Part 884.5300

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Choice Also Orient Surgical Gloves (Sterile)

  Class I

  FDA 510(k) K884328 Active Cleared 26 Apr 1989

• Piston Syringe with Needle

  Class II

  FDA 510(k) K883033 Active Cleared 31 Oct 1988

• Insulin Syringe

  Class II

  FDA 510(k) K883078 Active Cleared 31 Oct 1988

• Choice Condom

  Class II

  FDA 510(k) K863190 Active Cleared 3 Dec 1986

• Choice

  Class II

  FDA 510(k) K864482 Active Cleared 22 Dec 1986

• Face Mask: Comas Also Choice/Cone Mask: Polymas

  Class II

  FDA 510(k) K883705 Active Cleared 14 Nov 1988

• What materials are the Choice Also Kondum condoms made from, and how does this affect their use?

  The Choice Also Kondum condoms are made from either latex or synthetic polymer materials. The latex version is a natural rubber product, while the synthetic polymer option provides an alternative for individuals with latex allergies. Both materials are designed to provide a barrier against pregnancy and sexually transmitted infections during sexual intercourse.

• Are these condoms reusable, and if not, how should they be stored to maintain their integrity?

  The Choice Also Kondum condoms are explicitly designed as single-use products, meaning they should not be reused. To maintain sterility and structural integrity, they must be stored in a clean, dry environment, away from direct sunlight or extreme temperatures, until use.

• What sizes are available for the Choice Also Kondum condoms, and how do I determine the correct fit?

  The Choice Also Kondum condoms are available in multiple sizes, as indicated by the various FEI numbers listed in the specifications. While exact measurements aren’t provided, the manufacturer likely offers standard sizing options (e.g., small, medium, large) to accommodate different penis circumferences. For the best fit, refer to the packaging or manufacturer’s sizing guide, as an improper fit may reduce effectiveness.

• How is the sterility of the Choice Also Kondum condoms ensured, and what precautions should be taken during handling?

  The Choice Also Kondum condoms are supplied as sterile products, meaning they undergo processing to eliminate harmful microorganisms before packaging. To preserve sterility, avoid touching the condom’s surface with unwashed hands, and ensure the packaging remains intact until use. Once opened, use immediately to prevent contamination.

• What is the regulatory pathway for the Choice Also Kondum, and how does this affect its availability or use?

  The Choice Also Kondum received FDA 510(k) clearance under the Traditional review pathway, demonstrating it is substantially equivalent to a legally marketed predicate device. This clearance confirms its compliance with U.S. regulations for barrier contraceptives (product code HIS) under FDA classification HIS. Clinicians and buyers can rely on this approval for use in obstetrics/gynecology settings, though its primary purpose remains contraception.