FDA 510(k)

男性乳胶避孕套

K号: K203536 · 2021-09-03

决定日期2021-09-03

产品代码HIS

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决定实质等同

器械摘要

Male Latex Condom is the device name listed in this FDA 510(k) record. The listed applicant is Global Protection Corp.. It received FDA 510(k) clearance on 2021-09-03 under 510(k) number K203536. 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 Condom?

Male Latex Condom is a medical device that received FDA 510(k) clearance on 2021-09-03. The listed applicant is Global Protection Corp.. The 510(k) number is K203536.

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

Male Latex Condom received FDA 510(k) clearance on 2021-09-03, under 510(k) number K203536.

Who is the listed applicant for Male Latex Condom?

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

What is the FDA product code for Male Latex Condom?

The FDA product code for Male Latex Condom is HIS.

列明Global Protection Corp.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。

K243972普通水性润滑剂 K250142水基润滑剂 K243967ONE 氮化橡胶避孕套 K240896ONE 氮化橡胶避孕套 K223214无粉乳胶检查手套 K213087天然橡胶乳胶超声探头保护套

查看所有 8 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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