FDA 510(k)

一個尼龍乳膠避孕套

K 號：K240896 · 2024-08-23

決定日期2024-08-23

產品代碼MOL

諮詢委員會OB設備之醫療設備規範文本翻譯如下：關於OB設備的醫療設備規範文件：此設備已通過FDA認證，並獲得510(k)許可證。該設備的PMA申請已提交，並在NCT登錄編號為[編號]的研究中進行測試。相關文獻的PMID編號為[編號]。請參考以下識別碼和網址：識別碼：[識別碼] 網址：[網址] 政策：醫療規範-v1

決定相當於

器材摘要

ONE Nitrile 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 2024-08-23 under 510(k) number K240896. The device is classified under product code MOL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ONE Nitrile Condom?

ONE Nitrile Condom is a medical device that received FDA 510(k) clearance on 2024-08-23. The listed applicant is Global Protection Corp.. The 510(k) number is K240896.

When did ONE Nitrile Condom receive FDA 510(k) clearance?

ONE Nitrile Condom received FDA 510(k) clearance on 2024-08-23, under 510(k) number K240896.

Who is the listed applicant for ONE Nitrile 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 ONE Nitrile Condom?

The FDA product code for ONE Nitrile Condom is MOL.

其他以 Global Protection Corp. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關器械（代碼：MOL）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K252158Sagami 原創 002 聚氨酯男性避孕套Mayer Laboratories K243967一個尼龍乳膠避孕套Global Protection Corp.K241617杜蕾斯多異丙烯膠避孕套Rb Health (Us), LLC K240379特洛揚 SIS 合成橡膠避孕套，配備矽膠潤滑劑Church & Dwight Co., Inc.K232470多異戊二烯超大號避孕套Suretex Limited K23190845 微米聚異丁烯避孕套Suretex Limited

官方來源

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