FDA 510(k)

Onetouch 非對苯二酸酯潤滑膠

K 號：K220273 · 2022-10-21

申請人Thai Nippon Rubber Industry Public Company Limited.

決定日期2022-10-21

產品代碼NUC

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

Onetouch Non-paraben Lubricant Gel is the device name listed in this FDA 510(k) record. The listed applicant is Thai Nippon Rubber Industry Public Company Limited.. It received FDA 510(k) clearance on 2022-10-21 under 510(k) number K220273. The device is classified under product code NUC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Onetouch Non-paraben Lubricant Gel?

Onetouch Non-paraben Lubricant Gel is a medical device that received FDA 510(k) clearance on 2022-10-21. The listed applicant is Thai Nippon Rubber Industry Public Company Limited.. The 510(k) number is K220273.

When did Onetouch Non-paraben Lubricant Gel receive FDA 510(k) clearance?

Onetouch Non-paraben Lubricant Gel received FDA 510(k) clearance on 2022-10-21, under 510(k) number K220273.

Who is the listed applicant for Onetouch Non-paraben Lubricant Gel?

The FDA 510(k) record lists Thai Nippon Rubber Industry Public Company Limited. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Onetouch Non-paraben Lubricant Gel?

The FDA product code for Onetouch Non-paraben Lubricant Gel is NUC.

其他以 Thai Nippon Rubber Industry Public Company Limited. 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。

K210095Playboy 預防性硅膠潤滑劑 K211450Playboy 3 異型避孕套 K210294一觸螺旋避孕套 K171213一觸避孕套含苯佐卡因

相關器械（代碼：NUC）

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。

K260117EverslideSpecial Situations, LLC K253989HARU Orgasm by jack herer 水基潤滑劑（WL-OJ）；HARU Orgasm 水基潤滑劑（WL-OR）；HARU STEAMY 水基潤滑劑（WL-ST）Maxigen Biotech, Inc.K261905BUM油Bumlicious, LLC (DBA “Bumlicious”)K261177PINKSLIP 水基個人潤滑劑及保濕劑PINKSLIP, LLC K261909Plum Vagiceuticals™ 阴道潤滑栓PCCA, Inc.K254011流動水性個人潤滑劑LBDO Group, Inc.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。