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Safecon Condoms - Ribbed

by Quality Synthetics Intl, Inc.

510(k) K884454

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 NumberK884454 Date25 Apr 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  • Withdrawn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 Safecon Condoms - Ribbed is a Condom, a device classified as a medical specialty in Obstetrics/Gynecology. It is substantially equivalent to other devices in its class.

The device is supplied by Quality Synthetics Intl, Inc. and has been cleared with FDA 510K number K884454. The device is regulated under regulation number 884.5300 and has a product code of HIS. It is intended for use in the field of Obstetrics/Gynecology.

Other devices from Quality Synthetics Intl, Inc.

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 Safecon Condoms - Ribbed used for?

    The Safecon Condoms - Ribbed is intended for use in the field of Obstetrics/Gynecology, specifically as a contraceptive device.

  • Is the Safecon Condoms - Ribbed a single-use device?

    Although not explicitly stated, condoms are typically single-use devices due to their nature and purpose.

  • What is the regulatory status of the Safecon Condoms - Ribbed?

    The device has been cleared with FDA 510K number K884454, indicating it has been found substantially equivalent to other devices in its class.