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FDA 510(k)

無粉乳膠病人檢查手套，彩色（黃色）

K 號：K160675 · 2016-08-02

申請人Kaixing Plastic Products Co., Litd.
決定日期2016-08-02
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

Powder free vinyl patient examination glove, colored (yellow) is the device name listed in this FDA 510(k) record. The listed applicant is Kaixing Plastic Products Co., Litd.. It received FDA 510(k) clearance on 2016-08-02 under 510(k) number K160675. 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 Powder free vinyl patient examination glove, colored (yellow)?

Powder free vinyl patient examination glove, colored (yellow) is a medical device that received FDA 510(k) clearance on 2016-08-02. The listed applicant is Kaixing Plastic Products Co., Litd.. The 510(k) number is K160675.

When did Powder free vinyl patient examination glove, colored (yellow) receive FDA 510(k) clearance?

Powder free vinyl patient examination glove, colored (yellow) received FDA 510(k) clearance on 2016-08-02, under 510(k) number K160675.

Who is the listed applicant for Powder free vinyl patient examination glove, colored (yellow)?

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

What is the FDA product code for Powder free vinyl patient examination glove, colored (yellow)?

The FDA product code for Powder free vinyl patient examination glove, colored (yellow) 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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