FDA 510(k)

無粉觸感乙烯基檢查手套，透明

K 號：K252505 · 2025-08-28

決定日期2025-08-28

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

Powder-Free Vinyl Exam Gloves, clear is the device name listed in this FDA 510(k) record. The listed applicant is Basic Medical Technology, Inc.. It received FDA 510(k) clearance on 2025-08-28 under 510(k) number K252505. 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 Powder-Free Vinyl Exam Gloves, clear?

Powder-Free Vinyl Exam Gloves, clear is a medical device that received FDA 510(k) clearance on 2025-08-28. The listed applicant is Basic Medical Technology, Inc.. The 510(k) number is K252505.

When did Powder-Free Vinyl Exam Gloves, clear receive FDA 510(k) clearance?

Powder-Free Vinyl Exam Gloves, clear received FDA 510(k) clearance on 2025-08-28, under 510(k) number K252505.

Who is the listed applicant for Powder-Free Vinyl Exam Gloves, clear?

The FDA 510(k) record lists Basic Medical Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Powder-Free Vinyl Exam Gloves, clear?

The FDA product code for Powder-Free Vinyl Exam Gloves, clear is LYZ.

其他以 Basic Medical Technology, 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。

K260860無粉合成乙烯基檢查手套（藍色、黑色）K253160辛特克斯檢驗手套 K251716尼龍無粉 Exam 手套，經測試適合與化療藥物、芬太尼鹽酸、模擬胃酸及芬太尼鹽酸中的Xylazine使用 K250193奈米粉體無粉塵檢查手套 2.8，適用於化學治療藥物、鴉片啡鹽酸鹼，模擬胃酸（淺藍色，深藍色）測試 K250630氮化膽矽無粉檢查手套含玻尿酸，並經過與化學治療藥物、芬太尼鹽酸、模擬胃酸及芬太尼鹽酸中的噻唑嗪使用測試。K243792氮化膽粉無粉 Exam 手套，適用於化學治療藥物、鴉片類芬太尼鹽酸鹽（黑色、白色）測試

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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.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 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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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。