FDA 510(k)

一次性聚氯乙烯/丁腈混合醫療檢查手套

K 號：K212899 · 2021-12-11

決定日期2021-12-11

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 Blend Medical Examination Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Bytech(Dongtai) Co., Ltd.. It received FDA 510(k) clearance on 2021-12-11 under 510(k) number K212899. 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 Blend Medical Examination Gloves?

Disposable Vinyl/Nitrile Blend Medical Examination Gloves is a medical device that received FDA 510(k) clearance on 2021-12-11. The listed applicant is Bytech(Dongtai) Co., Ltd.. The 510(k) number is K212899.

When did Disposable Vinyl/Nitrile Blend Medical Examination Gloves receive FDA 510(k) clearance?

Disposable Vinyl/Nitrile Blend Medical Examination Gloves received FDA 510(k) clearance on 2021-12-11, under 510(k) number K212899.

Who is the listed applicant for Disposable Vinyl/Nitrile Blend Medical Examination Gloves?

The FDA 510(k) record lists Bytech(Dongtai) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Vinyl/Nitrile Blend Medical Examination Gloves?

The FDA product code for Disposable Vinyl/Nitrile Blend Medical Examination Gloves is LYZ.

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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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。

器材摘要

常見問題

相關臨床試驗

相關器械（代碼：LYZ）

官方來源