FDA 510(k)

Lifestyles 零潤滑乳膠男性避孕套

K 號：K163107 · 2017-01-23

決定日期2017-01-23

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

Lifestyles Zero Lubricated Latex Male Condom is the device name listed in this FDA 510(k) record. The listed applicant is Ansell Healthcare Products, LLC. It received FDA 510(k) clearance on 2017-01-23 under 510(k) number K163107. 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 Lifestyles Zero Lubricated Latex Male Condom?

Lifestyles Zero Lubricated Latex Male Condom is a medical device that received FDA 510(k) clearance on 2017-01-23. The listed applicant is Ansell Healthcare Products, LLC. The 510(k) number is K163107.

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

Lifestyles Zero Lubricated Latex Male Condom received FDA 510(k) clearance on 2017-01-23, under 510(k) number K163107.

Who is the listed applicant for Lifestyles Zero Lubricated Latex Male Condom?

The FDA 510(k) record lists Ansell Healthcare Products, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Lifestyles Zero Lubricated Latex Male Condom?

The FDA product code for Lifestyles Zero Lubricated Latex Male Condom is HIS.

其他以 Ansell Healthcare Products, LLC 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。

K230079多異戊二烯外科手套，經測試適合與化療藥物使用並具有低皮膚炎潛在風險 K213289Gammex® PI Plus Glove-in-Glove™ 系統已經通過測試，適合與化學治療藥物使用 K212148非无菌無粉多氯丙烯檢查手套（藍色）已檢驗適合與化療藥物使用 K210401Microflex 硝基膠病人檢查手套藍色款已經測試可用於化療藥物及芬太尼鹽酸鹽，Microflex 硝基膠病人檢查手套綠色款已經測試可用於化療藥物及芬太尼鹽酸鹽，Microflex 硝基膠病人檢查手套黑色款已經測試可用於化療藥物及芬太尼鹽酸鹽 K200671Microflex 硝基病人檢查手套，含洋甘菊和金合歡，藍綠粉三色，已經檢測過 K190018Gammex Non Latex PI White Polyisoprene Surgical Gloves 經測試可用於化療藥物

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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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