FDA 510(k)

特洛揚火與冰潤滑男性天然橡膠乳膠避孕套

K 號：K221906 · 2022-09-28

決定日期2022-09-28

產品代碼HIS

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

TROJAN Fire & Ice lubricated male natural rubber latex condom 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 2022-09-28 under 510(k) number K221906. The device is classified under product code HIS. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TROJAN Fire & Ice lubricated male natural rubber latex condom?

TROJAN Fire & Ice lubricated male natural rubber latex condom is a medical device that received FDA 510(k) clearance on 2022-09-28. The listed applicant is Church & Dwight Co., Inc.. The 510(k) number is K221906.

When did TROJAN Fire & Ice lubricated male natural rubber latex condom receive FDA 510(k) clearance?

TROJAN Fire & Ice lubricated male natural rubber latex condom received FDA 510(k) clearance on 2022-09-28, under 510(k) number K221906.

Who is the listed applicant for TROJAN Fire & Ice lubricated male natural rubber latex condom?

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 Fire & Ice lubricated male natural rubber latex condom?

The FDA product code for TROJAN Fire & Ice lubricated male natural rubber latex condom is HIS.

其他以 Church & Dwight Co., Inc. 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。

K243640特洛揚™超細肋線快樂膠乳避孕套（潤滑型）（特洛揚™超細肋線快樂膠乳避孕套）K240379特洛揚 SIS 合成橡膠避孕套，配備矽膠潤滑劑 K221431TROJAN™ 她的快樂加熱男性天然橡膠乳膠避孕套，搭配加熱潤滑劑 K203818Replens 長效陰道潤膚劑 K193450Pre-Seed™ 孕育潤滑劑 K180764特洛伊TM 藍色個人潤滑劑（H2O 敏感觸碰個人潤滑劑）

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相關器械（代碼：HIS）

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。

官方來源

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