FDA 510(k)

LifeStyles® HydraFeel天然橡胶乳胶避孕套

K号: K252521 · 2025-11-18

决定日期2025-11-18

产品代码HIS

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决定实质等同

器械摘要

LifeStyles® HydraFeel Natural Rubber Latex Condom is the device name listed in this FDA 510(k) record. The listed applicant is Suretex Limited. It received FDA 510(k) clearance on 2025-11-18 under 510(k) number K252521. 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 LifeStyles® HydraFeel Natural Rubber Latex Condom?

LifeStyles® HydraFeel Natural Rubber Latex Condom is a medical device that received FDA 510(k) clearance on 2025-11-18. The listed applicant is Suretex Limited. The 510(k) number is K252521.

When did LifeStyles® HydraFeel Natural Rubber Latex Condom receive FDA 510(k) clearance?

LifeStyles® HydraFeel Natural Rubber Latex Condom received FDA 510(k) clearance on 2025-11-18, under 510(k) number K252521.

Who is the listed applicant for LifeStyles® HydraFeel Natural Rubber Latex Condom?

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

What is the FDA product code for LifeStyles® HydraFeel Natural Rubber Latex Condom?

The FDA product code for LifeStyles® HydraFeel Natural Rubber Latex Condom is HIS.

列明Suretex Limited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。

K232470聚异戊二烯超大号避孕套 K23190845微米聚异丁烯避孕套 K232279LifeStyles NRL纹理避孕套 K221243OFNat 润滑剂 (L15)K213921Microthin Natural Rubber Latex Condom

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

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