ELAZ 硅膠無粉檢查手套
K 號：K213604 · 2022-04-03
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決定日期2022-04-03
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
ELAZ Nitrile Powder Free Examination Glove is the device name listed in this FDA 510(k) record. The listed applicant is Protect Gloves Co., Ltd.. It received FDA 510(k) clearance on 2022-04-03 under 510(k) number K213604. 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 ELAZ Nitrile Powder Free Examination Glove?
ELAZ Nitrile Powder Free Examination Glove is a medical device that received FDA 510(k) clearance on 2022-04-03. The listed applicant is Protect Gloves Co., Ltd.. The 510(k) number is K213604.
When did ELAZ Nitrile Powder Free Examination Glove receive FDA 510(k) clearance?
ELAZ Nitrile Powder Free Examination Glove received FDA 510(k) clearance on 2022-04-03, under 510(k) number K213604.
Who is the listed applicant for ELAZ Nitrile Powder Free Examination Glove?
The FDA 510(k) record lists Protect Gloves Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ELAZ Nitrile Powder Free Examination Glove?
The FDA product code for ELAZ Nitrile Powder Free Examination Glove 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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