FDA 510(k)

男性乳胶避孕套

K号: K222611 · 2022-11-28

申请人Suzhou Colour-Way New Material Co., Ltd.

决定日期2022-11-28

产品代码HIS

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决定实质等同

器械摘要

Male Latex Condoms is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Colour-Way New Material Co., Ltd.. It received FDA 510(k) clearance on 2022-11-28 under 510(k) number K222611. 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 Male Latex Condoms?

Male Latex Condoms is a medical device that received FDA 510(k) clearance on 2022-11-28. The listed applicant is Suzhou Colour-Way New Material Co., Ltd.. The 510(k) number is K222611.

When did Male Latex Condoms receive FDA 510(k) clearance?

Male Latex Condoms received FDA 510(k) clearance on 2022-11-28, under 510(k) number K222611.

Who is the listed applicant for Male Latex Condoms?

The FDA 510(k) record lists Suzhou Colour-Way New Material Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Male Latex Condoms?

The FDA product code for Male Latex Condoms is HIS.

列明Suzhou Colour-Way New Material Co., Ltd.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。

K240790聚异戊二烯手术手套 K222620灭菌乳胶外科手套

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.

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