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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 a medical device manufactured by Lelo, Inc.. It received FDA 510(k) clearance on 2025-03-07 under approval 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. It is manufactured by Lelo, Inc.. The 510(k) number is K243421.

When was Lelo Hex Lubricated Natural Rubber Latex Condom approved by the FDA?

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

What company makes Lelo Hex Lubricated Natural Rubber Latex Condom?

Lelo Hex Lubricated Natural Rubber Latex Condom is manufactured by Lelo, Inc..

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.

Other Devices by Lelo, Inc.

K160644Lelo Hex Natural Rubber Latex Condom K162511LELO RESPECT HEX Natural Rubber Latex Condom

Related Devices (Code: HIS)

K153016aoni Natural Rubber Latex CondomGuangzhou Daming United Rubber Products , Ltd. K161915Trojan XOXO Ribbed Male Natural Rubber Latex Condom with Silicone and Aloe LubricantChurch & Dwight Co., Inc. K161545Trojan XOXO Thin Male Natural Rubber Latex Condom with Silicone and Aloe LubricantChurch & Dwight Co., Inc. K161195Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors)M3 Global Enterprises, LLC K160644Lelo Hex Natural Rubber Latex CondomLelo, Inc. K172414JUD custom fit condomGlobal Mailer Partners, LLC

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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