氮化膽胺檢查手套 無粉
K 號：K212921 · 2021-12-24
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決定日期2021-12-24
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
Nitrile Examination Golves Powder Free is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Standard Health Co.,Ltd. It received FDA 510(k) clearance on 2021-12-24 under 510(k) number K212921. 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 Nitrile Examination Golves Powder Free?
Nitrile Examination Golves Powder Free is a medical device that received FDA 510(k) clearance on 2021-12-24. The listed applicant is Jiangsu Standard Health Co.,Ltd. The 510(k) number is K212921.
When did Nitrile Examination Golves Powder Free receive FDA 510(k) clearance?
Nitrile Examination Golves Powder Free received FDA 510(k) clearance on 2021-12-24, under 510(k) number K212921.
Who is the listed applicant for Nitrile Examination Golves Powder Free?
The FDA 510(k) record lists Jiangsu Standard Health Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Nitrile Examination Golves Powder Free?
The FDA product code for Nitrile Examination Golves Powder Free 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。
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
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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