天然橡胶乳胶男用避孕套
K号: K250034 · 2025-07-11
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决定日期2025-07-11
产品代码HIS
咨询委员会OB
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决定实质等同
器械摘要
Natural rubber latex male condom is the device name listed in this FDA 510(k) record. The listed applicant is Shaoguan Regenex Pharmaceuticals Co., Ltd.. It received FDA 510(k) clearance on 2025-07-11 under 510(k) number K250034. The device is classified under product code HIS. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Natural rubber latex male condom?
Natural rubber latex male condom is a medical device that received FDA 510(k) clearance on 2025-07-11. The listed applicant is Shaoguan Regenex Pharmaceuticals Co., Ltd.. The 510(k) number is K250034.
When did Natural rubber latex male condom receive FDA 510(k) clearance?
Natural rubber latex male condom received FDA 510(k) clearance on 2025-07-11, under 510(k) number K250034.
Who is the listed applicant for Natural rubber latex male condom?
The FDA 510(k) record lists Shaoguan Regenex Pharmaceuticals Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Natural rubber latex male condom?
The FDA product code for Natural rubber latex male condom is HIS.
相关临床试验
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。
相关器械（代码：HIS）
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。
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官方来源
在 FDA 数据库中查看 →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。
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