FDA 510(k)

可生物降解尼龍粉末無粉塵檢查手套，經測試適合與化療藥物及芬太尼鹽酸（融合顏色）使用

K 號：K223437 · 2023-05-17

決定日期2023-05-17

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

Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour) 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 2023-05-17 under 510(k) number K223437. 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 Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour)?

Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour) is a medical device that received FDA 510(k) clearance on 2023-05-17. The listed applicant is Hartalega NGC Sdn. Bhd.. The 510(k) number is K223437.

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

Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour) received FDA 510(k) clearance on 2023-05-17, under 510(k) number K223437.

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

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 Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour)?

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

其他以 Hartalega NGC Sdn. Bhd. 為申請人之記錄

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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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