FDA 510(k)

醫療用PVC檢查手套

K 號：K210821 · 2021-07-09

申請人Jiangxi Hongda Medical Equipment Group , Ltd.

決定日期2021-07-09

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

Medical PVC Examination Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Jiangxi Hongda Medical Equipment Group , Ltd.. It received FDA 510(k) clearance on 2021-07-09 under 510(k) number K210821. 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 Medical PVC Examination Gloves?

Medical PVC Examination Gloves is a medical device that received FDA 510(k) clearance on 2021-07-09. The listed applicant is Jiangxi Hongda Medical Equipment Group , Ltd.. The 510(k) number is K210821.

When did Medical PVC Examination Gloves receive FDA 510(k) clearance?

Medical PVC Examination Gloves received FDA 510(k) clearance on 2021-07-09, under 510(k) number K210821.

Who is the listed applicant for Medical PVC Examination Gloves?

The FDA 510(k) record lists Jiangxi Hongda Medical Equipment Group , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medical PVC Examination Gloves?

The FDA product code for Medical PVC Examination Gloves is LYZ.

其他以 Jiangxi Hongda Medical Equipment Group , Ltd. 為申請人之記錄

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。

K211753無菌針筒，配安全針 K210578醫用尼龍檢查手套（無電力，藍色）K163160無菌單次使用輸液套管 K163162單次使用无菌皮下注射安全針 K163161無菌一次性針筒

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

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