Skip to content

One Touch Spiral Condom

by Thai Nippon Rubber Industry Public Company Limited

510(k) K210294

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 26 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K210294↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 26 Oct 2026. What this means

Regulatory status

as of registry sync 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK210294 Date23 Sep 2021ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 26 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
HIS
FDA applicant
Thai Nippon Rubber Industry Public Company Limited.
Device Class
Class II
Regulation
21 CFR Part 884.5300
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 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 One Touch Spiral Condom is a barrier contraceptive device designed to prevent pregnancy by providing a physical barrier between semen and the cervix during sexual intercourse. It is classified as a condom and functions as a non-hormonal method of birth control, reducing the risk of unintended pregnancy through mechanical obstruction of sperm entry into the uterus.

This device is supplied as a single-use, non-sterile product intended for use in obstetrics and gynecology settings. It is classified under FDA regulation number 884.5300 and falls under device class II. The One Touch Spiral Condom is not intended for MRI use and must be handled according to manufacturer guidelines for proper application and disposal. No additional regulatory authorisations beyond the stated 510K clearance and MDR are mentioned.

Other devices from Thai Nippon Rubber Industry Public Company Limited

See all devices from Thai Nippon Rubber Industry Public Company Limited →