FDA 510(k)

特洛伊™超细条纹Ecstasy乳胶避孕套（润滑型）（特洛伊™超细条纹Ecstasy）

K号: K243640 · 2025-02-21

决定日期2025-02-21

产品代码HIS

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决定实质等同

器械摘要

Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed Ecstasy) is the device name listed in this FDA 510(k) record. The listed applicant is Church & Dwight Co., Inc.. It received FDA 510(k) clearance on 2025-02-21 under 510(k) number K243640. 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 Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed Ecstasy)?

Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed Ecstasy) is a medical device that received FDA 510(k) clearance on 2025-02-21. The listed applicant is Church & Dwight Co., Inc.. The 510(k) number is K243640.

When did Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed Ecstasy) receive FDA 510(k) clearance?

Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed Ecstasy) received FDA 510(k) clearance on 2025-02-21, under 510(k) number K243640.

Who is the listed applicant for Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed Ecstasy)?

The FDA 510(k) record lists Church & Dwight Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed Ecstasy)?

The FDA product code for Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed Ecstasy) is HIS.

列明Church & Dwight Co., Inc.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。

K240379TROJAN SIS 合成乳胶避孕套带硅润滑剂 K221906TROJAN 火与冰润滑男性天然橡胶乳胶避孕套 K221431TROJAN™ 她的愉悦保暖男性天然橡胶乳胶避孕套带保暖润滑剂 K203818Replens长效阴道保湿剂 K193450Pre-Seed®生育润滑剂 K180764特洛伊TM 阿祖尔个人润滑剂（H2O敏感触感个人润滑剂）

查看所有 12 个设备 →

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。

K262108FAMA男性乳胶避孕套 - 水性润滑剂（超薄型）；FAMA男性乳胶避孕套 - 水性润滑剂（普通型）；FAMA男性乳胶避孕套 - 水性润滑剂（肋纹型）；FAMA男性乳胶避孕套 - 水性润滑剂（点状型）；FAMA男性乳胶避孕套 - 水性润滑剂（非规则形状型）；MO男性乳胶避孕套 - 水性润滑剂（超薄型）；MO男性乳胶避孕套 - 水性润滑剂（普通型）；MO男性乳胶避孕套 - 水性润滑剂（肋纹型）；MO男性乳胶避孕套 - 水性润滑剂（点状型）；MOShanghai Personage Hygiene Products Co., Ltd.K252622男性乳胶避孕套HAOkamoto USA, Inc.K252521LifeStyles® HydraFeel天然橡胶乳胶避孕套Suretex Limited K250034天然橡胶乳胶男用避孕套Shaoguan Regenex Pharmaceuticals Co., Ltd.K243421Lelo Hex 润滑天然乳胶安全套Lelo, Inc.K2435840.04 ZERO ZERO FOUR男性乳胶避孕套Okamoto USA, Inc.

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。