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SAFE.N.SURE Condom

by Ashai Co., Ltd. Australia 510(k)

510(k) K852620

Product code HIS

Overview

SAFE.N.SURE is a condom classified as a Class II medical device under the Obstetrics/Gynecology specialty. It is intended for use as a barrier contraceptive to reduce the risk of pregnancy and sexually transmitted infections.

The device is supplied sterile and is intended for single use. It is not reusable and should be discarded after use. Storage conditions are not specified in the provided data.

Summary written by AI from registry data, 26 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK852620 Date31 Oct 1985ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

Full name
Safe.n.sure
510(k) Number
FDA Product Code
HIS
FDA applicant
Ashai Co. , Ltd.
Device Class
Class II
Regulation
21 CFR Part 884.5300
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the SAFE.N.SURE device used for?

    The SAFE.N.SURE is a barrier contraceptive intended to reduce the risk of pregnancy and sexually transmitted infections.

  • Is the SAFE.N.SURE condom sterile?

    Yes, the device is supplied sterile and is intended for single use only.

  • Can the SAFE.N.SURE condom be reused?

    No, the device is intended for single use and should be discarded after use.

  • What is the regulatory classification of the SAFE.N.SURE?

    The SAFE.N.SURE is classified as a Class II medical device under the Obstetrics/Gynecology specialty.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K852620 24 fields · synced 22 Oct 2026