FDA 510(k)

一次性無粉乳膠檢查手套，藍色，已測試與化療藥物及芬太尼鹽酸鹽及息拉唑使用

K 號：K244034 · 2025-02-06

申請人Ever Global (Vietnam) Enterprise Corporation

決定日期2025-02-06

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

Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate and Xylazine is the device name listed in this FDA 510(k) record. The listed applicant is Ever Global (Vietnam) Enterprise Corporation. It received FDA 510(k) clearance on 2025-02-06 under 510(k) number K244034. 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 Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate and Xylazine?

Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate and Xylazine is a medical device that received FDA 510(k) clearance on 2025-02-06. The listed applicant is Ever Global (Vietnam) Enterprise Corporation. The 510(k) number is K244034.

When did Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate and Xylazine receive FDA 510(k) clearance?

Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate and Xylazine received FDA 510(k) clearance on 2025-02-06, under 510(k) number K244034.

Who is the listed applicant for Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate and Xylazine?

The FDA 510(k) record lists Ever Global (Vietnam) Enterprise Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate and Xylazine?

The FDA product code for Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate and Xylazine is LZA.

其他以 Ever Global (Vietnam) Enterprise Corporation 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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