FDA 510(k)

水性潤滑劑

K 號：K250142 · 2025-08-08

決定日期2025-08-08

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

Water-based Lubricant 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 2025-08-08 under 510(k) number K250142. 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 Water-based Lubricant?

Water-based Lubricant is a medical device that received FDA 510(k) clearance on 2025-08-08. The listed applicant is Global Protection Corp.. The 510(k) number is K250142.

When did Water-based Lubricant receive FDA 510(k) clearance?

Water-based Lubricant received FDA 510(k) clearance on 2025-08-08, under 510(k) number K250142.

Who is the listed applicant for Water-based Lubricant?

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 Water-based Lubricant?

The FDA product code for Water-based Lubricant is NUC.

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：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

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