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Extra Protection Polyurethane Condom

by Apex Medical Technologies, Inc.

510(k) K922688

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK922688 Date4 May 1995ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 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  • Withdrawn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
MOL
Device Class
Class II
Regulation
21 CFR Part 884.5300
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

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

The Extra Protection Polyurethane Condom is a synthetic condom designed for use as a barrier device. It is classified as a synthetic condom under regulation number 884.5300.

This device is identified by K-number K922688 and has received FDA 510(k) clearance. It is manufactured by Apex Medical Technologies, Inc.

Other devices from Apex Medical Technologies, Inc.

See all devices from Apex Medical Technologies, Inc. →

Questions

AI-generated answers, 26 Sep 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 intended use of the Extra Protection Polyurethane Condom?

    This device is designed to function as a synthetic barrier condom. It is classified under regulation number 884.5300 for use as a barrier device.

  • Who is the manufacturer of this synthetic condom?

    The Extra Protection Polyurethane Condom is manufactured by Apex Medical Technologies, Inc., located in San Diego, California.

  • Has this device received regulatory clearance?

    Yes, this device has received FDA 510(k) clearance under K-number K922688. It was determined to be substantially equivalent to other devices in its class.