FDA 510(k)

0.04 ZERO ZERO FOUR男性乳胶避孕套

K号: K243584 · 2025-02-18

决定日期2025-02-18

产品代码HIS

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决定实质等同

器械摘要

0.04 ZERO ZERO FOUR Male Latex Condom is the device name listed in this FDA 510(k) record. The listed applicant is Okamoto USA, Inc.. It received FDA 510(k) clearance on 2025-02-18 under 510(k) number K243584. 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 0.04 ZERO ZERO FOUR Male Latex Condom?

0.04 ZERO ZERO FOUR Male Latex Condom is a medical device that received FDA 510(k) clearance on 2025-02-18. The listed applicant is Okamoto USA, Inc.. The 510(k) number is K243584.

When did 0.04 ZERO ZERO FOUR Male Latex Condom receive FDA 510(k) clearance?

0.04 ZERO ZERO FOUR Male Latex Condom received FDA 510(k) clearance on 2025-02-18, under 510(k) number K243584.

Who is the listed applicant for 0.04 ZERO ZERO FOUR Male Latex Condom?

The FDA 510(k) record lists Okamoto USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 0.04 ZERO ZERO FOUR Male Latex Condom?

The FDA product code for 0.04 ZERO ZERO FOUR Male Latex Condom is HIS.

列明Okamoto USA, 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。

K252622男性乳胶避孕套HA K203541Okamoto 002 润滑聚氨酯男性避孕套 K192669极薄003，零零三

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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