FDA 510(k)

一次性無粉膠製檢查手套，米色/透明

K 號：K221980 · 2023-02-06

申請人Ever Global (Vietnam) Enterprise Corporation

決定日期2023-02-06

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 Examination Gloves, Beige/Clear is the device name listed in this FDA 510(k) record. The listed applicant is Ever Global (Vietnam) Enterprise Corporation. It received FDA 510(k) clearance on 2023-02-06 under 510(k) number K221980. 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 Examination Gloves, Beige/Clear?

Disposable Powder Free Vinyl Examination Gloves, Beige/Clear is a medical device that received FDA 510(k) clearance on 2023-02-06. The listed applicant is Ever Global (Vietnam) Enterprise Corporation. The 510(k) number is K221980.

When did Disposable Powder Free Vinyl Examination Gloves, Beige/Clear receive FDA 510(k) clearance?

Disposable Powder Free Vinyl Examination Gloves, Beige/Clear received FDA 510(k) clearance on 2023-02-06, under 510(k) number K221980.

Who is the listed applicant for Disposable Powder Free Vinyl Examination Gloves, Beige/Clear?

The FDA 510(k) record lists Ever Global (Vietnam) Enterprise Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Powder Free Vinyl Examination Gloves, Beige/Clear?

The FDA product code for Disposable Powder Free Vinyl Examination Gloves, Beige/Clear is LYZ.

其他以 Ever Global (Vietnam) Enterprise Corporation 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。

K252244一次性無粉乳膠檢查手套，藍色，已測試與化療藥物、芬太尼鹽酸、副醛、胃酸、胃酸中的芬太尼及胃酸中的副醛相容 K244034一次性無粉乳膠檢查手套，藍色，已測試與化療藥物及芬太尼鹽酸鹽及息拉唑使用 K220992一次性無粉膠質檢查手套，黑色/藍色/紫色 K190403一次性無粉乳膠檢查手套，白色，已檢驗可與化療藥物使用，一次性無粉乳膠檢查手套，藍色，已檢驗可與化療藥物使用

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.K220992一次性無粉膠質檢查手套，黑色/藍色/紫色Ever Global (Vietnam) Enterprise Corporation

官方來源

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