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FDA 510(k)

Lelo Hex Lubricated Natural Rubber Latex Condom

K-Number: K243421 · 2025-03-07

ApplicantLelo, Inc.
Decision Date2025-03-07
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Lelo Hex Lubricated Natural Rubber Latex Condom is the device name listed in this FDA 510(k) record. The listed applicant is Lelo, Inc.. It received FDA 510(k) clearance on 2025-03-07 under 510(k) number K243421. The device is classified under product code HIS. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Lelo Hex Lubricated Natural Rubber Latex Condom?

Lelo Hex Lubricated Natural Rubber Latex Condom is a medical device that received FDA 510(k) clearance on 2025-03-07. The listed applicant is Lelo, Inc.. The 510(k) number is K243421.

When did Lelo Hex Lubricated Natural Rubber Latex Condom receive FDA 510(k) clearance?

Lelo Hex Lubricated Natural Rubber Latex Condom received FDA 510(k) clearance on 2025-03-07, under 510(k) number K243421.

Who is the listed applicant for Lelo Hex Lubricated Natural Rubber Latex Condom?

The FDA 510(k) record lists Lelo, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Lelo Hex Lubricated Natural Rubber Latex Condom?

The FDA product code for Lelo Hex Lubricated Natural Rubber Latex Condom is HIS.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06557499A 3-way Crossover Clinical Investigation to Assess the Performance of Two Different Sized Polyurethane Condoms Versus a Latex Condom in Healthy Monogamous Couples.COMPLETED

Other records listing Lelo, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K162511LELO RESPECT HEX Natural Rubber Latex CondomK160644Lelo Hex Natural Rubber Latex Condom

Related Devices (Code: HIS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252622Male Latex Condom HAOkamoto USA, Inc.K252521LifeStyles® HydraFeel Natural Rubber Latex CondomSuretex LimitedK250034Natural rubber latex male condomShaoguan Regenex Pharmaceuticals Co., Ltd.K243640Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed Ecstasy)Church & Dwight Co., Inc.K2435840.04 ZERO ZERO FOUR Male Latex CondomOkamoto USA, Inc.K232279LifeStyles NRL Textured CondomSuretex Limited

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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