Kiss of Mint Non-Lubricated Condom

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

Full name

Kiss of Mint(Tm) Non-Lubricated Condom

510(k) Number

K882389 ↗

FDA Product Code

HIS

Device Class

Class II

Regulation

21 CFR Part 884.5300

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Nuda-Plus Condom W/Spermicidal Lubricant

  Class II

  FDA 510(k) K822792 Active Cleared 30 Sep 1982

• Condom

  Class II

  FDA 510(k) K940045 Active Cleared 30 Jan 1995

• Patient Examination Gloves (Latex)

  Class I

  FDA 510(k) K892289 Active Cleared 23 Jun 1989

• Derma Prene

  Class I

  FDA 510(k) K820665 Active Cleared 3 May 1982

• G.S.A. Colored Condoms

  Class II

  FDA 510(k) K901112 Active Cleared 27 Mar 1990

• Ansell Conform Green Examination Gloves

  Class I

  FDA 510(k) K897081 Active Cleared 26 Mar 1990

See all devices from Ansell, Inc. →

• What is the Kiss of Mint Non-Lubricated Condom used for?

  The Kiss of Mint Non-Lubricated Condom is a barrier contraceptive designed to prevent sexually transmitted infections (STIs) and unintended pregnancies during vaginal intercourse. It works by creating a physical barrier between partners, reducing the risk of pathogen transmission and conception. It is not intended for use in any other type of intercourse or medical procedure.

• Is the Kiss of Mint Non-Lubricated Condom reusable or single-use?

  This condom is explicitly designed for single-use only. It is not intended to be reused or sterilized after use. Reusing condoms can compromise their effectiveness and increase the risk of breakage or failure, which could lead to unintended pregnancies or STI transmission. Always use a new condom for each act of intercourse.

• How is the Kiss of Mint Non-Lubricated Condom supplied?

  The condom is supplied as a single-use product, meaning each condom is individually packaged for one-time use. It is not lubricated, which distinguishes it from other condoms that may include internal or external lubricants. The lack of lubrication is intentional, as it aligns with its specific design for use without additional lubrication.

• Does the Kiss of Mint Non-Lubricated Condom require sterilization?

  No, the Kiss of Mint Non-Lubricated Condom is not intended for sterilization. It is a single-use device, and sterilization is not applicable or necessary. After use, it should be discarded in accordance with local waste disposal guidelines. Attempting to sterilize or reuse it could compromise its integrity and safety.

• What regulatory approval does the Kiss of Mint Non-Lubricated Condom hold?

  The Kiss of Mint Non-Lubricated Condom holds FDA 510(k) clearance under the classification of Class II, with the clearance number K882389. This clearance indicates that the device is substantially equivalent to a legally marketed predicate device and meets FDA requirements for safety and effectiveness. The product is also regulated under FDA regulation number 884.5300.