Skip to content

Condom (Rubber Latex) Kilroy

by Rfsu

510(k) K894533

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK894533 Date18 Dec 1989ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HIS
Device Class
Class II
Regulation
21 CFR Part 884.5300
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Condom (Rubber Latex) Kilroy is a barrier contraceptive device designed to prevent pregnancy and sexually transmitted infections during sexual intercourse. It is classified as a Class II medical device and constructed from natural rubber latex, providing a physical barrier to sperm and pathogens.

This single-use, non-sterile condom is intended for use in obstetrics/gynecology settings for contraception. It received FDA 510(k) clearance (K894533) under the Traditional pathway on December 18, 1989, and is regulated under FDA regulation 884.5300. The device is distributed under product code HIS and should be stored in a cool, dry place away from direct sunlight.

Condom (Rubber Latex) Kilroy

Other devices from Rfsu

See all devices from Rfsu →

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Kilroy Latex Condom used for?

    The Kilroy Latex Condom is a barrier contraceptive designed to prevent pregnancy and sexually transmitted infections during sexual intercourse. It works by creating a physical barrier between sperm and reproductive tissues, reducing the risk of both conception and pathogen transmission. This device is specifically intended for use in obstetrics and gynecology settings.

  • Is the Kilroy Latex Condom sterile?

    No, the Kilroy Latex Condom is non-sterile. It is intended for single-use and does not undergo sterilization processes, which aligns with its classification as a non-sterile barrier device for contraception. Always ensure proper hygiene before use.

  • How should the Kilroy Latex Condom be stored?

    The Kilroy Latex Condom should be stored in a cool, dry place away from direct sunlight. Proper storage conditions help maintain the integrity of the latex material and ensure the device remains effective for its intended use.

  • What regulatory pathway was used for FDA clearance?

    The Kilroy Latex Condom received FDA 510(k) clearance under the Traditional pathway on December 18, 1989, with clearance number K894533. This pathway demonstrates that the device is substantially equivalent to a legally marketed predicate device, meeting FDA requirements for safety and effectiveness.

  • What product code and regulatory classification apply to this condom?

    The Kilroy Latex Condom is classified as a Class II medical device and is regulated under FDA regulation number 884.5300. It is distributed under the product code HIS, which categorizes it within the FDA’s medical device hierarchy for obstetrics/gynecology contraceptives.