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Condom-Multipal Styles

by Circle Rubber Corp.

510(k) K813172

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 NumberK813172 Date5 Mar 1982ClearedStatusActive

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  • Withdrawn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, 27 Sep 2026

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

Condom-Multipal Styles is a contraceptive device designed for barrier protection during sexual intercourse. It is available in multiple styles to accommodate different preferences and needs. The device is manufactured by Circle Rubber Corp. and is classified under product code HIS.

This device is supplied as a single-use product and is not intended for reuse. It has received FDA 510(k) clearance with the K number K813172, indicating it is substantially equivalent to other legally marketed devices. The device is regulated under FDA regulation number 884.5300 and is classified as Class II medical device.

Other devices from Circle Rubber Corp.

Questions

AI-generated answers, 27 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 Condom-Multipal Styles device?

    It is a barrier contraceptive designed to provide protection against pregnancy and sexually transmitted infections during sexual intercourse. The device works by physically covering the penis, preventing direct contact with the partner’s mucous membranes.

  • How is the product supplied and can it be reused?

    The condom is supplied as a single‑use product packaged individually. It is not intended for reuse because repeated handling can compromise material integrity, increasing the risk of breakage and reducing its effectiveness as a barrier.

  • What variations are available to meet different preferences?

    Condom‑Multipal Styles is offered in multiple styles, allowing users to select options that differ in texture, fit, or added features such as lubrication. These variations help accommodate personal comfort and sexual experience preferences while maintaining the same safety standards.

  • What regulatory pathway did this device follow?

    The device received FDA 510(k) clearance (K813172), indicating it is substantially equivalent to a legally marketed predicate. It is classified under product code HIS and regulated under FDA regulation number 884.5300 as a Class II medical device.