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LELO RESPECT HEX Natural Rubber Latex Condom

by Lelo, Inc.

510(k) K162511

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 · Special NumberK162511 Date13 Jan 2017ClearedStatusActive

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  • Withdrawn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, 24 Sep 2026

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

LELO RESPECT HEX Natural Rubber Latex Condom is a natural rubber latex condom designed as a physical barrier for contraception and prevention of sexually transmitted infections. It features a hexagonal structural pattern and is worn by the user during sexual intercourse.

It is supplied as a straight-walled, hexagonal-textured sheath with a nipple end, intended for over-the-counter use by the general population. The device is classified as a Class II medical device under FDA regulation number 884.5300 and has received FDA 510(k) clearance (K162511) as substantially equivalent to a predicate device.

Other devices from Lelo, Inc.

Questions

AI-generated answers, 24 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 LELO RESPECT HEX Natural Rubber Latex Condom used for?

    It is designed as a physical barrier for contraception and prevention of sexually transmitted infections, worn by the user during sexual intercourse to reduce risk of pregnancy and disease transmission.

  • How is the LELO RESPECT HEX Natural Rubber Latex Condom supplied and intended for use?

    It is supplied as a straight-walled, hexagonal-textured sheath with a nipple end and is intended for over-the-counter use by the general population during sexual activity.

  • Is the LELO RESPECT HEX Natural Rubber Latex Condom sterile or single-use?

    As a condom, it is intended for single-use only and is not supplied sterile; it is designed for one-time use during intercourse and should be discarded after each use.