FDA 510(k)

一次性無粉乳膠檢查手套，藍色，已測試與化療藥物使用 Compatibility

K 號：K190736 · 2019-12-23

決定日期2019-12-23

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 is the device name listed in this FDA 510(k) record. The listed applicant is Ever Growth (Vietnam) Co. , Ltd.. It received FDA 510(k) clearance on 2019-12-23 under 510(k) number K190736. 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?

Disposable Powder Free Nitrile Examination Glove,Blue Color, Tested For Use With Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2019-12-23. The listed applicant is Ever Growth (Vietnam) Co. , Ltd.. The 510(k) number is K190736.

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

Disposable Powder Free Nitrile Examination Glove,Blue Color, Tested For Use With Chemotherapy Drugs received FDA 510(k) clearance on 2019-12-23, under 510(k) number K190736.

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

The FDA 510(k) record lists Ever Growth (Vietnam) Co. , Ltd. 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?

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

其他以 Ever Growth (Vietnam) Co. , Ltd. 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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