FDA 510(k)

氮化膽矽無粉檢查手套，適用於化學治療藥物及芬太尼鹽酸鹽（藍色）測試使用

K 號：K243818 · 2025-01-08

決定日期2025-01-08

產品代碼LZA

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) is the device name listed in this FDA 510(k) record. The listed applicant is Hartalega NGC Sdn. Bhd.. It received FDA 510(k) clearance on 2025-01-08 under 510(k) number K243818. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)?

Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) is a medical device that received FDA 510(k) clearance on 2025-01-08. The listed applicant is Hartalega NGC Sdn. Bhd.. The 510(k) number is K243818.

When did Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) receive FDA 510(k) clearance?

Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) received FDA 510(k) clearance on 2025-01-08, under 510(k) number K243818.

Who is the listed applicant for Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)?

FDA 510(k) 記錄將 Hartalega NGC Sdn. Bhd. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)?

The FDA product code for Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) is LZA.

其他以 Hartalega NGC Sdn. Bhd. 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：LZA）

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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官方來源

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