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FDA 510(k)

無粉乳膠檢查手套（藍色、白色和黑色），已檢驗可與化療藥物及芬太尼使用

K 號：K222815 · 2022-12-04

申請人Zibo Lanhua Medical Packaging Material Co., Ltd.
決定日期2022-12-04
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

Powder Free Nitrile Examination Gloves (Blue, White and Black), Tested For Use With Chemotherapy Drugs and Fentanyl is the device name listed in this FDA 510(k) record. The listed applicant is Zibo Lanhua Medical Packaging Material Co., Ltd.. It received FDA 510(k) clearance on 2022-12-04 under 510(k) number K222815. 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 Powder Free Nitrile Examination Gloves (Blue, White and Black), Tested For Use With Chemotherapy Drugs and Fentanyl?

Powder Free Nitrile Examination Gloves (Blue, White and Black), Tested For Use With Chemotherapy Drugs and Fentanyl is a medical device that received FDA 510(k) clearance on 2022-12-04. The listed applicant is Zibo Lanhua Medical Packaging Material Co., Ltd.. The 510(k) number is K222815.

When did Powder Free Nitrile Examination Gloves (Blue, White and Black), Tested For Use With Chemotherapy Drugs and Fentanyl receive FDA 510(k) clearance?

Powder Free Nitrile Examination Gloves (Blue, White and Black), Tested For Use With Chemotherapy Drugs and Fentanyl received FDA 510(k) clearance on 2022-12-04, under 510(k) number K222815.

Who is the listed applicant for Powder Free Nitrile Examination Gloves (Blue, White and Black), Tested For Use With Chemotherapy Drugs and Fentanyl?

The FDA 510(k) record lists Zibo Lanhua Medical Packaging Material Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Powder Free Nitrile Examination Gloves (Blue, White and Black), Tested For Use With Chemotherapy Drugs and Fentanyl?

The FDA product code for Powder Free Nitrile Examination Gloves (Blue, White and Black), Tested For Use With Chemotherapy Drugs and Fentanyl is LZA.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

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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