FDA 510(k)

杜蕾斯聚异戊二烯避孕套

K号: K241617 · 2025-02-28

决定日期2025-02-28

产品代码MOL

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决定实质等同

器械摘要

Durex Polyisoprene Condom is the device name listed in this FDA 510(k) record. The listed applicant is Rb Health (Us), LLC. It received FDA 510(k) clearance on 2025-02-28 under 510(k) number K241617. The device is classified under product code MOL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Durex Polyisoprene Condom?

Durex Polyisoprene Condom is a medical device that received FDA 510(k) clearance on 2025-02-28. The listed applicant is Rb Health (Us), LLC. The 510(k) number is K241617.

When did Durex Polyisoprene Condom receive FDA 510(k) clearance?

Durex Polyisoprene Condom received FDA 510(k) clearance on 2025-02-28, under 510(k) number K241617.

Who is the listed applicant for Durex Polyisoprene Condom?

The FDA 510(k) record lists Rb Health (Us), LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Durex Polyisoprene Condom?

The FDA product code for Durex Polyisoprene Condom is MOL.

列明Rb Health (Us), LLC为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K230781Belle Sensilube K213892Grosz 加热液体，Grosz Play 刺激，Grosz KY Yours & Mine K220489杜蕾斯帕特诺斯CloseFit，杜蕾斯帕特诺斯Regular K222068杜蕾斯Penck III Regular K211152Durex含苯佐卡因避孕套 K213647杜蕾斯帕特诺斯Wide

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官方来源

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