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相容

K 號：K193555 · 2020-06-04

申請人Ever Global (Vietnam) Enterprise Corp

決定日期2020-06-04

產品代碼LZC

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 is the device name listed in this FDA 510(k) record. The listed applicant is Ever Global (Vietnam) Enterprise Corp. It received FDA 510(k) clearance on 2020-06-04 under 510(k) number K193555. The device is classified under product code LZC. 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?

Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate is a medical device that received FDA 510(k) clearance on 2020-06-04. The listed applicant is Ever Global (Vietnam) Enterprise Corp. The 510(k) number is K193555.

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

Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate received FDA 510(k) clearance on 2020-06-04, under 510(k) number K193555.

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

The FDA 510(k) record lists Ever Global (Vietnam) Enterprise Corp 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?

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

其他以 Ever Global (Vietnam) Enterprise 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：LZC）

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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