Skip to content

Lelo Hex Natural Rubber Latex Condom

by Lelo, Inc.

510(k) K160644

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 NumberK160644 Date30 Jun 2016ClearedStatusActive

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  • Withdrawn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 Lelo Hex Natural Rubber Latex Condom is a condom (FDA classification HIS) designed as a barrier device for contraception and the prevention of sexually transmitted infections. It is manufactured from natural rubber latex and features a hexagonal-textured, straight-walled sheath with a nipple end, providing both mechanical protection and tactile feedback during use.

This device is intended for single-use and is supplied sterile. It is classified as a Class II medical device under FDA regulation 884.5300, with a 510(k) clearance (K160644) for substantial equivalence. The condom is packaged individually and requires no additional preparation before use. No MRI safety information or reusable variants are specified in the regulatory data.

Other devices from Lelo, 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 Lelo Hex Natural Rubber Latex Condom designed for?

    This condom is a barrier device intended for contraception and the prevention of sexually transmitted infections (STIs). Its hexagonal-textured, straight-walled design provides mechanical protection while also offering tactile feedback during use, enhancing user experience.

  • How is the Lelo Hex condom supplied and prepared for use?

    The condom is individually packaged and supplied sterile, requiring no additional preparation before use. It is designed for single-use only, ensuring hygiene and safety with each application.

  • Is the Lelo Hex condom reusable or intended for multiple uses?

    No, the Lelo Hex condom is explicitly designed for single-use only. This ensures optimal protection and sterility, as reuse could compromise its integrity and increase the risk of infection or failure.

  • What material is the condom made from, and does it have any special features?

    The condom is manufactured from natural rubber latex, which provides a durable and flexible barrier. Its distinguishing feature is the hexagonal-textured surface, which offers both enhanced protection and tactile feedback during use.

  • Are there any specific storage requirements for the Lelo Hex condom?

    While the device data does not specify detailed storage instructions, condoms like this are generally recommended to be stored in a cool, dry place away from direct sunlight and extreme temperatures. Avoid storing them in pockets or glove compartments, as heat or friction could damage the latex.