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FDA 510(k)

一次性聚氯乙烯丁腈合成手套 非粉化

K 號：K211516 · 2021-08-24

申請人Tangshan Hongyun Plastic Products Co., Ltd.
決定日期2021-08-24
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

Disposable Vinyl Nitrile Synthetic Gloves Powder Free is the device name listed in this FDA 510(k) record. The listed applicant is Tangshan Hongyun Plastic Products Co., Ltd.. It received FDA 510(k) clearance on 2021-08-24 under 510(k) number K211516. 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 Disposable Vinyl Nitrile Synthetic Gloves Powder Free?

Disposable Vinyl Nitrile Synthetic Gloves Powder Free is a medical device that received FDA 510(k) clearance on 2021-08-24. The listed applicant is Tangshan Hongyun Plastic Products Co., Ltd.. The 510(k) number is K211516.

When did Disposable Vinyl Nitrile Synthetic Gloves Powder Free receive FDA 510(k) clearance?

Disposable Vinyl Nitrile Synthetic Gloves Powder Free received FDA 510(k) clearance on 2021-08-24, under 510(k) number K211516.

Who is the listed applicant for Disposable Vinyl Nitrile Synthetic Gloves Powder Free?

The FDA 510(k) record lists Tangshan Hongyun Plastic Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Vinyl Nitrile Synthetic Gloves Powder Free?

The FDA product code for Disposable Vinyl Nitrile Synthetic Gloves Powder Free 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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

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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