FDA 510(k)

可生物降解無粉塵聚氯乙烯檢查手套，藍色、綠色和白色

K 號：K213144 · 2021-12-22

決定日期2021-12-22

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

Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors is the device name listed in this FDA 510(k) record. The listed applicant is Shen Wei USA, Inc.. It received FDA 510(k) clearance on 2021-12-22 under 510(k) number K213144. 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 Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors?

Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors is a medical device that received FDA 510(k) clearance on 2021-12-22. The listed applicant is Shen Wei USA, Inc.. The 510(k) number is K213144.

When did Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors receive FDA 510(k) clearance?

Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors received FDA 510(k) clearance on 2021-12-22, under 510(k) number K213144.

Who is the listed applicant for Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors?

The FDA 510(k) record lists Shen Wei USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors?

The FDA product code for Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors is LYZ.

其他以 Shen Wei USA, Inc. 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。

K213141可生物降解無粉乳膠檢查手套，藍色和綠色，低皮膚炎潛在風險，已測試與化療藥物、芬太尼鹽酸、模擬胃酸及芬太尼鹽酸-模擬胃酸溶液使用。K213142可生物降解無粉塵 flock 纏織丁腈檢查手套，黑色和灰色，已測試與化療藥物、芬太尼鹽酸、模擬胃酸及芬太尼鹽酸模擬胃酸溶液使用。K211620可生物降解無粉乳膠檢查手套，自然色、藍色、黑色和綠色，並標示蛋白質含量聲明（50微克或以下）K211455無粉乳膠檢查手套，含洋甘菊、橘色及橘白色 K202085可生物降解無粉乳膠檢查手套，低皮膚炎潛在風險聲明，綠色 K202083可生物降解無粉塵丁腈檢查手套，藍白色，具有低皮膚炎潛在風險聲明，並經過與化療藥物使用之測試

查看所有 19 項裝置 →

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。