Prime Condom

No FDA recalls on record, checked 22 Oct 2026.

Full name

Prime

510(k) Number

K830691 ↗

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. →

• Is the Prime Condom suitable for use in MRI environments, and if not, why not?

  The Prime Condom is not indicated for MRI use. The device specifications explicitly state there is no mention of MRI safety, meaning it has not been tested or validated for compatibility with magnetic resonance imaging environments. Clinicians should avoid using it in MRI settings to prevent potential risks to patients or interference with imaging equipment.

• How should the Prime Condom be stored, and what conditions should be avoided?

  The Prime Condom requires no special storage conditions beyond protecting it from extreme temperatures and moisture. It is recommended to store it in a cool, dry place, away from direct sunlight or humidity, to maintain its integrity and functionality. Avoiding exposure to these elements ensures the condom remains effective for its intended single-use application.

• Can the Prime Condom be reused, or is it designed for single-use only?

  The Prime Condom is explicitly designed for single-use only. As a latex barrier contraceptive, it is not intended to be reused, as reuse could compromise its effectiveness in preventing pregnancy or sexually transmitted infections. Following single-use guidelines ensures proper hygiene and safety for both partners.

• What regulatory pathway was followed for the Prime Condom’s FDA clearance, and what does that mean for its use?

  The Prime Condom received FDA clearance through a Traditional 510(k) pathway, classified as *Substantially Equivalent* to a predicate device. This means the FDA determined it meets the same performance standards as an existing, legally marketed condom under the Obstetrics/Gynecology specialty category (product code HIS). Clinicians can rely on this clearance to confirm the device adheres to U.S. medical device standards for its intended use in preventing pregnancy and STIs during vaginal intercourse.

• Is the Prime Condom sterile, and if not, what does that mean for clinical settings?

  The Prime Condom is non-sterile, meaning it is not intended for sterile procedures or invasive clinical applications. While it is suitable for use in obstetrics and gynecology settings as a barrier contraceptive, clinicians should follow standard hygiene practices (e.g., handwashing) before and after use. Sterility is not required for its contraceptive function, but non-sterile devices should not be used in sterile surgical environments.