Lelo Hex Lubricated Natural Rubber Latex Condom— 510(k) K243421

Name: FDA 510(k) clearance K243421
Creator: U.S. Food and Drug Administration
Published: 2025-03-07

Substantially Equivalent

Lelo, Inc.

FDA 510(k) clearance K243421 for Lelo Hex Lubricated Natural Rubber Latex Condom, Substantially Equivalent on 2025-03-07. Applicant: Lelo, Inc.. Device class: 2.

Clearance details

Applicant: Lelo, Inc.
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 2024-11-04
Decision date: 2025-03-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

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K252521 — LifeStyles® HydraFeel Natural Rubber Latex Condom2025-11-18
K250034 — Natural rubber latex male condom2025-07-11
K243640 — Trojan Ultra Ribbed Ecstasy latex condom with lubricant (Trojan Ultra Ribbed Ecstasy)2025-02-21
K243584 — 0.04 ZERO ZERO FOUR Male Latex Condom2025-02-18

More clearances from Lelo, Inc.

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K162511 — LELO RESPECT HEX Natural Rubber Latex Condom2017-01-13
K160644 — Lelo Hex Natural Rubber Latex Condom2016-06-30

Data sourced from openFDA. This site is unofficial and independent of the FDA.