FDA 510(k)

ONE 氮化橡胶避孕套

K号: K243967 · 2025-04-08

决定日期2025-04-08

产品代码MOL

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决定实质等同

器械摘要

ONE Nitrile Condom is the device name listed in this FDA 510(k) record. The listed applicant is Global Protection Corp.. It received FDA 510(k) clearance on 2025-04-08 under 510(k) number K243967. 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 ONE Nitrile Condom?

ONE Nitrile Condom is a medical device that received FDA 510(k) clearance on 2025-04-08. The listed applicant is Global Protection Corp.. The 510(k) number is K243967.

When did ONE Nitrile Condom receive FDA 510(k) clearance?

ONE Nitrile Condom received FDA 510(k) clearance on 2025-04-08, under 510(k) number K243967.

Who is the listed applicant for ONE Nitrile Condom?

The FDA 510(k) record lists Global Protection Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ONE Nitrile Condom?

The FDA product code for ONE Nitrile Condom is MOL.

列明Global Protection Corp.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。

K243972普通水性润滑剂 K250142水基润滑剂 K240896ONE 氮化橡胶避孕套 K223214无粉乳胶检查手套 K213087天然橡胶乳胶超声探头保护套 K203536男性乳胶避孕套

查看所有 8 个设备 →

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。