FDA 510(k)

無粉製膠質病人檢查手套，黃色

K 號：K191092 · 2019-07-22

申請人Anhui Intco Medical Products Co., Ltd.

決定日期2019-07-22

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

Powder-Free Vinyl Patient Examination Gloves, Yellow Color is the device name listed in this FDA 510(k) record. The listed applicant is Anhui Intco Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2019-07-22 under 510(k) number K191092. 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 Patient Examination Gloves, Yellow Color?

Powder-Free Vinyl Patient Examination Gloves, Yellow Color is a medical device that received FDA 510(k) clearance on 2019-07-22. The listed applicant is Anhui Intco Medical Products Co., Ltd.. The 510(k) number is K191092.

When did Powder-Free Vinyl Patient Examination Gloves, Yellow Color receive FDA 510(k) clearance?

Powder-Free Vinyl Patient Examination Gloves, Yellow Color received FDA 510(k) clearance on 2019-07-22, under 510(k) number K191092.

Who is the listed applicant for Powder-Free Vinyl Patient Examination Gloves, Yellow Color?

The FDA 510(k) record lists Anhui Intco Medical Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Powder-Free Vinyl Patient Examination Gloves, Yellow Color?

The FDA product code for Powder-Free Vinyl Patient Examination Gloves, Yellow Color is LYZ.

其他以 Anhui Intco Medical Products 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。

K231365氮化膽胺病人檢查手套，含透明質酸藍色，並經過與化學治療藥物及芬太尼鹽酸檢驗，又名Synguard C+ 氮化膽胺檢查手套 K233598無粉劑氰膠檢查手套 2.8 藍色，非无菌，並經過與化療藥物、芬太尼鹽酸鹽及選擇其他藥物使用的測試。K190095無粉塵透明膠質病人檢查手套

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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