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FDA 510(k)

Synmax合成病人檢查乙烯手套，無粉，藍色

K 號：K153028 · 2016-02-05

申請人Zibo Huiying Medical Products, Co. , Ltd.
決定日期2016-02-05
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

Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue is the device name listed in this FDA 510(k) record. The listed applicant is Zibo Huiying Medical Products, Co. , Ltd.. It received FDA 510(k) clearance on 2016-02-05 under 510(k) number K153028. 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 Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue?

Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue is a medical device that received FDA 510(k) clearance on 2016-02-05. The listed applicant is Zibo Huiying Medical Products, Co. , Ltd.. The 510(k) number is K153028.

When did Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue receive FDA 510(k) clearance?

Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue received FDA 510(k) clearance on 2016-02-05, under 510(k) number K153028.

Who is the listed applicant for Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue?

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

What is the FDA product code for Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue?

The FDA product code for Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue 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。

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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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