FDA 510(k)

特洛伊XOXO超薄男性天然乳胶避孕套，含硅酮和芦荟润滑剂

K号: K161545 · 2016-08-26

决定日期2016-08-26

产品代码HIS

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决定实质等同

器械摘要

Trojan XOXO Thin Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant 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 2016-08-26 under 510(k) number K161545. 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 XOXO Thin Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant?

Trojan XOXO Thin Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant is a medical device that received FDA 510(k) clearance on 2016-08-26. The listed applicant is Church & Dwight Co., Inc.. The 510(k) number is K161545.

When did Trojan XOXO Thin Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant receive FDA 510(k) clearance?

Trojan XOXO Thin Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant received FDA 510(k) clearance on 2016-08-26, under 510(k) number K161545.

Who is the listed applicant for Trojan XOXO Thin Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant?

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 XOXO Thin Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant?

The FDA product code for Trojan XOXO Thin Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant 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。

K243640特洛伊™超细条纹Ecstasy乳胶避孕套（润滑型）（特洛伊™超细条纹Ecstasy）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

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.K243640特洛伊™超细条纹Ecstasy乳胶避孕套（润滑型）（特洛伊™超细条纹Ecstasy）Church & Dwight Co., Inc.

官方来源

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