Skip to content

SUSTAIN Condom

by Hollender Sustainable Brands, LLC

510(k) K131866

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 · Abbreviated NumberK131866 Date1 May 2014ClearedStatusActive

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  • Withdrawn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)

Full name
Sustain
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, 19 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 SUSTAIN Condom is a barrier contraceptive device designed to prevent sexually transmitted infections and unintended pregnancies during vaginal intercourse. It is classified as a Class II medical device under FDA regulations, adhering to standards for condom performance and safety.

Supplied as a single-use, non-sterile product, the SUSTAIN Condom is intended for use in obstetrics/gynecology settings. It is not MRI-compatible and must be stored in a cool, dry place away from direct sunlight. Authorized under FDA 510(k) clearance (K131866), it complies with regulation number 884.5300 and is distributed under product code HIS.

Questions

AI-generated answers, 19 Sep 2026

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

  • Is the SUSTAIN Condom suitable for use in MRI environments, and if not, why should clinicians avoid it in such settings?

    The SUSTAIN Condom is explicitly labeled as not MRI-compatible. Clinicians should avoid using it in MRI environments because the materials or components may react unpredictably to magnetic fields, potentially compromising safety or imaging accuracy. Always verify device compatibility before use in MRI settings.

  • How should the SUSTAIN Condom be stored to maintain its integrity and effectiveness?

    The SUSTAIN Condom must be stored in a cool, dry place away from direct sunlight. Proper storage conditions help preserve its physical properties and ensure it remains effective for its intended single-use application. Avoid exposure to extreme temperatures or moisture.

  • Is the SUSTAIN Condom reusable, or is it designed for single-use only?

    The SUSTAIN Condom is intended for single-use only. It is not designed or cleared for reuse, which is a standard practice for barrier contraceptives to ensure safety and effectiveness. Discard it after one use to comply with manufacturer guidelines.

  • What regulatory pathway was followed for the FDA clearance of the SUSTAIN Condom, and what does that mean for its safety and performance?

    The SUSTAIN Condom received FDA 510(k) clearance (K131866) under an Abbreviated pathway, classified as Substantially Equivalent (SESE) to a predicate device. This means the FDA determined it meets the same performance and safety standards as existing condoms, ensuring it complies with FDA regulation 884.5300 for barrier contraceptives. The clearance was reviewed by the Obstetrics/Gynecology (OB) Advisory Committee.