FDA 510(k)

一次性無粉膠製檢查手套，透明/黃色

K 號：K172357 · 2017-12-29

決定日期2017-12-29

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 Powder Free Vinyl Exam Glove, Clear/Yellow is the device name listed in this FDA 510(k) record. The listed applicant is Ever Growth (Vietnam) Co. , Ltd.. It received FDA 510(k) clearance on 2017-12-29 under 510(k) number K172357. 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 Powder Free Vinyl Exam Glove, Clear/Yellow?

Disposable Powder Free Vinyl Exam Glove, Clear/Yellow is a medical device that received FDA 510(k) clearance on 2017-12-29. The listed applicant is Ever Growth (Vietnam) Co. , Ltd.. The 510(k) number is K172357.

When did Disposable Powder Free Vinyl Exam Glove, Clear/Yellow receive FDA 510(k) clearance?

Disposable Powder Free Vinyl Exam Glove, Clear/Yellow received FDA 510(k) clearance on 2017-12-29, under 510(k) number K172357.

Who is the listed applicant for Disposable Powder Free Vinyl Exam Glove, Clear/Yellow?

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

What is the FDA product code for Disposable Powder Free Vinyl Exam Glove, Clear/Yellow?

The FDA product code for Disposable Powder Free Vinyl Exam Glove, Clear/Yellow is LYZ.

其他以 Ever Growth (Vietnam) Co. , 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。

K190942一次性無粉乳膠檢查手套，粉紅/黑色 K190860一次性無粉乳膠檢查手套，適用於化學治療藥物使用，白色，一次性無粉乳膠檢查手套，適用於化學治療藥物使用，橙色 K190736一次性無粉乳膠檢查手套，藍色，已測試與化療藥物使用 Compatibility

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

在 FDA 資料庫中查看 →

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。