Sagami 原创型 002 聚氨酯男性避孕套
K号: K252158 · 2026-03-30
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决定日期2026-03-30
产品代码MOL
咨询委员会OB
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决定实质等同
器械摘要
Sagami Original 002 Polyurethane Male Condom is the device name listed in this FDA 510(k) record. The listed applicant is Mayer Laboratories. It received FDA 510(k) clearance on 2026-03-30 under 510(k) number K252158. 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 Sagami Original 002 Polyurethane Male Condom?
Sagami Original 002 Polyurethane Male Condom is a medical device that received FDA 510(k) clearance on 2026-03-30. The listed applicant is Mayer Laboratories. The 510(k) number is K252158.
When did Sagami Original 002 Polyurethane Male Condom receive FDA 510(k) clearance?
Sagami Original 002 Polyurethane Male Condom received FDA 510(k) clearance on 2026-03-30, under 510(k) number K252158.
Who is the listed applicant for Sagami Original 002 Polyurethane Male Condom?
The FDA 510(k) record lists Mayer Laboratories as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Sagami Original 002 Polyurethane Male Condom?
The FDA product code for Sagami Original 002 Polyurethane Male Condom is MOL.
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：MOL）
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。
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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