FDA 510(k)

3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)

K 號：K222578 · 2023-05-18

決定日期2023-05-18

產品代碼KKX

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) is the device name listed in this FDA 510(k) record. The listed applicant is 3M Company. It received FDA 510(k) clearance on 2023-05-18 under 510(k) number K222578. The device is classified under product code KKX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)?

3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) is a medical device that received FDA 510(k) clearance on 2023-05-18. The listed applicant is 3M Company. The 510(k) number is K222578.

When did 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) receive FDA 510(k) clearance?

3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) received FDA 510(k) clearance on 2023-05-18, under 510(k) number K222578.

Who is the listed applicant for 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)?

The FDA 510(k) record lists 3M Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)?

The FDA product code for 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) is KKX.

其他以 3M Company 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。

K2435013M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490M K2425383M® Attest® 超级快速读数生物指示剂 1493；3M® Attest® 超级快速蒸汽重力清晰挑战包 1493PCDG；3M® Attest® 自动读取器 490；3M® Attest® 自动读取器 490H；3M® Attest® 迷你自动读取器 490M K2419593M® Attest® 超级快速蒸汽清晰挑战包 (1492PCD)；3M® Attest® 自动读取器 (490)；3M® Attest® 自动读取器 (490H)；3M® Attest® 迷你自动读取器 (490M)K2417103M® Attest® 超级快速读数生物指示剂 1492V；3M® Attest® 自动读取器 490；3M® Attest® 自动读取器 490H；3M® Attest® 迷你自动读取器 490M K2415423M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD)K2407173M® Attest® 快速读数生物指示剂 1295 和 3M® Attest® 蒸汽化氢氧化氢三参数化学指示剂 1348/1348E

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相關器械（代碼：KKX）

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。

K230645BeneHold™ 外科切口覆蓋布，配CHG抗菌II型Avery Dennison Medical , Ltd.K202208BeneHold外科切口巾，含CHG抗菌劑Avery Dennison Belgie Bvba K200238ControlRad 無菌蓋Controlrad, Inc.K163556MediClear 預手術Covalontechnologies, Inc.

官方來源

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