乙烯基檢查手套，無粉，透明
K 號：K161390 · 2016-12-19
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決定日期2016-12-19
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
Vinyl Exam Gloves, Powder Free, Clear is the device name listed in this FDA 510(k) record. The listed applicant is Zibo Hongchin Plastic and Rubber Co., Ltd.. It received FDA 510(k) clearance on 2016-12-19 under 510(k) number K161390. 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 Vinyl Exam Gloves, Powder Free, Clear?
Vinyl Exam Gloves, Powder Free, Clear is a medical device that received FDA 510(k) clearance on 2016-12-19. The listed applicant is Zibo Hongchin Plastic and Rubber Co., Ltd.. The 510(k) number is K161390.
When did Vinyl Exam Gloves, Powder Free, Clear receive FDA 510(k) clearance?
Vinyl Exam Gloves, Powder Free, Clear received FDA 510(k) clearance on 2016-12-19, under 510(k) number K161390.
Who is the listed applicant for Vinyl Exam Gloves, Powder Free, Clear?
The FDA 510(k) record lists Zibo Hongchin Plastic and Rubber Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Vinyl Exam Gloves, Powder Free, Clear?
The FDA product code for Vinyl Exam Gloves, Powder Free, Clear 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。
K260860無粉合成乙烯基檢查手套（藍色、黑色）Basic Medical Technology, Inc.K252467一次性膠質檢查手套Viet Phu Trade and Import Export Co., Ltd.K252505無粉觸感乙烯基檢查手套，透明Basic Medical Technology, Inc.K241252一次性膠質檢查手套Anqing Pukang Medical Technology Co., Ltd.K230046乙烯檢查手套Guangdong Kingfa Sci. & Tech.Co., Ltd.K221980一次性無粉膠製檢查手套，米色/透明Ever Global (Vietnam) Enterprise Corporation
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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