合成尼龍檢查手套
K 號：K212488 · 2021-11-26
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決定日期2021-11-26
產品代碼LYZ
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
Synthetic Nitrile Examination Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Shandong Hongxin Chemicals Co., Ltd.. It received FDA 510(k) clearance on 2021-11-26 under 510(k) number K212488. The device is classified under product code LYZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Synthetic Nitrile Examination Gloves?
Synthetic Nitrile Examination Gloves is a medical device that received FDA 510(k) clearance on 2021-11-26. The listed applicant is Shandong Hongxin Chemicals Co., Ltd.. The 510(k) number is K212488.
When did Synthetic Nitrile Examination Gloves receive FDA 510(k) clearance?
Synthetic Nitrile Examination Gloves received FDA 510(k) clearance on 2021-11-26, under 510(k) number K212488.
Who is the listed applicant for Synthetic Nitrile Examination Gloves?
The FDA 510(k) record lists Shandong Hongxin Chemicals Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Synthetic Nitrile Examination Gloves?
The FDA product code for Synthetic Nitrile Examination Gloves is LYZ.
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：LYZ）
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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