FDA 510(k)

單次使用醫療聚氯乙烯檢查手套（透明，無顏色）

K 號：K182043 · 2018-09-21

申請人Hebei Titans Hongsen Medical Technology Co., Ltd.

決定日期2018-09-21

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

Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) is the device name listed in this FDA 510(k) record. The listed applicant is Hebei Titans Hongsen Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-09-21 under 510(k) number K182043. 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 Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored)?

Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) is a medical device that received FDA 510(k) clearance on 2018-09-21. The listed applicant is Hebei Titans Hongsen Medical Technology Co., Ltd.. The 510(k) number is K182043.

When did Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) receive FDA 510(k) clearance?

Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) received FDA 510(k) clearance on 2018-09-21, under 510(k) number K182043.

Who is the listed applicant for Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored)?

The FDA 510(k) record lists Hebei Titans Hongsen Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored)?

The FDA product code for Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) is LYZ.

其他以 Hebei Titans Hongsen Medical Technology 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。

K240361無粉綠色尼龍檢查手套（XS/S/M/L/XL）；無粉紅色尼龍檢查手套（XS/S/M/L/XL）；無粉紫色尼龍檢查手套（XS/S/M/L/XL）K223895一次性硝基橡胶檢查手套 K221374一次性醫用橡膠檢查手套（超小/小/中/大/加大）K212097一次性醫療外科口罩 K211229乙烯基複合檢驗手套 K181130無粉藍色尼龍檢查手套，已檢驗適合與化療藥物使用

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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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