Prophylactic Condom

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

510(k) Number

K854622 ↗

FDA Product Code

HIS

Device Class

Class II

Regulation

21 CFR Part 884.5300

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Medelec 2110 and 2114 EEG

  Class II

  FDA 510(k) K922548 Active Cleared 3 Nov 1992

• Sapphire 4ME EMG/Ep System

  Class II

  FDA 510(k) K912775 Active Cleared 8 Nov 1991

• Blade, Scalpel

  Class I

  FDA 510(k) K854561 Active Cleared 2 Dec 1985

• Electroencephalograph Recording System

  Class II

  FDA 510(k) K920127 Active Cleared 10 Jun 1992

• Prophylactic (Condom) MR. Johnny

  Class II

  FDA 510(k) K865106 Active Cleared 20 May 1987

• Blades, Scalpel Carbon Steet

  Class I

  FDA 510(k) K854860 Active Cleared 24 Dec 1985

See all devices from Medelec Intl. Corp. →

• What is the Medelec prophylactic condom used for?

  The Medelec prophylactic condom is a barrier contraceptive designed to prevent unintended pregnancy and sexually transmitted infections (STIs) during sexual intercourse. It works by creating a physical barrier between partners, collecting semen to minimize exposure risk. This device is specifically intended for single-use in obstetrics and gynecology settings, ensuring safety and compliance with medical standards.

• How is the prophylactic condom supplied and prepared for use?

  The prophylactic condom is supplied sterile and ready for immediate use—no additional preparation is required. It comes pre-packaged to maintain sterility, ensuring it meets clinical hygiene standards before application. This eliminates the need for cleaning or sterilization procedures, making it convenient for healthcare settings.

• Is the Medelec prophylactic condom reusable or single-use?

  This device is explicitly designed for single-use only. After use, it should be discarded to prevent contamination and ensure patient safety. The sterile packaging and FDA classification as a barrier contraceptive reinforce its intended one-time application in medical settings.

• What materials is the prophylactic condom made from?

  The prophylactic condom is constructed from latex or synthetic materials, providing a durable yet flexible barrier. The material choice ensures compatibility with most skin types while maintaining effectiveness in preventing semen transmission. Synthetic alternatives are also available for users with latex allergies.

• How should the prophylactic condom be stored?

  Store the prophylactic condom in a cool, dry place away from direct sunlight or extreme temperatures. Ensure the sterile packaging remains intact until use to preserve sterility. Avoid storing in areas prone to moisture or chemical exposure, as this could compromise the device’s integrity or effectiveness.