FDA 510(k)

無粉製膠質病人檢查手套（黃色、白色）

K 號：K180260 · 2018-06-12

申請人Shanxi Hongjin Plastic Technology Co., Ltd.

決定日期2018-06-12

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, White) is the device name listed in this FDA 510(k) record. The listed applicant is Shanxi Hongjin Plastic Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-06-12 under 510(k) number K180260. 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, White)?

Powder Free Vinyl Patient Examination Gloves (Yellow, White) is a medical device that received FDA 510(k) clearance on 2018-06-12. The listed applicant is Shanxi Hongjin Plastic Technology Co., Ltd.. The 510(k) number is K180260.

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

Powder Free Vinyl Patient Examination Gloves (Yellow, White) received FDA 510(k) clearance on 2018-06-12, under 510(k) number K180260.

Who is the listed applicant for Powder Free Vinyl Patient Examination Gloves (Yellow, White)?

The FDA 510(k) record lists Shanxi Hongjin Plastic Technology 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, White)?

The FDA product code for Powder Free Vinyl Patient Examination Gloves (Yellow, White) is LYZ.

其他以 Shanxi Hongjin Plastic Technology Co., Ltd. 為申請人之記錄

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K232550氮化膽固醇檢查手套，雙色黑藍 K232353無粉乳膠檢查手套（黑色）K230779無粉劑氰膠檢查手套（黑色），已檢驗適合與化療藥物及芬太尼鹽酸使用 K220229無粉乳膠檢查手套，橙色 K211604無粉劑式尼龍檢查手套（藍色），已檢驗適合與化療藥物使用 K180381無粉製膠質病人檢查手套

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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.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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