FDA 510(k)

藍色非无菌無粉劑丁腈檢查手套，已檢驗可與化療藥物使用

K 號：K172525 · 2017-11-13

決定日期2017-11-13

產品代碼LZC

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

Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs is the device name listed in this FDA 510(k) record. The listed applicant is Central Medicare Sdn Bhd. It received FDA 510(k) clearance on 2017-11-13 under 510(k) number K172525. The device is classified under product code LZC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs?

Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2017-11-13. The listed applicant is Central Medicare Sdn Bhd. The 510(k) number is K172525.

When did Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs receive FDA 510(k) clearance?

Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs received FDA 510(k) clearance on 2017-11-13, under 510(k) number K172525.

Who is the listed applicant for Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs?

The FDA 510(k) record lists Central Medicare Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs?

The FDA product code for Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs is LZC.

其他以 Central Medicare Sdn Bhd 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。

K230681藍色非消毒粉塵無乳膠檢查手套，經測試可與化療藥物、胃酸及芬太尼使用。K223752黑色非无菌粉塵無乳膠檢查手套，適用於與化療藥物使用，含氯喹、環孢素A、逆轉病毒、胃酸及芬太尼檢測。K230875藍色非無菌粉末無菌乳膠檢查手套，經化療藥物使用測試，具有胃酸和芬太尼通透性抗性聲明 K230564綠色非消毒無粉乳膠檢查手套 K213437藍色非無菌粉末無菌乳膠檢查手套，經化療藥物使用測試，具有胃酸和芬太尼通透性抗性聲明 K211022藍色非消毒粉塵型尼龍檢查手套，已測試與化療藥物使用，並具有胃酸及芬太尼通透性抵抗聲明。

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相關器械（代碼：LZC）

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。

K252313卡迪那爾健康公司硅膠檢查手套長袖Cardinalhealth K243959無粉劑氰膠檢查手套（紫、黑、綠），已檢驗可與化療藥物、芬太尼鹽酸鹽及選擇其他藥物使用Lingshi Hongruida Health Protection Technology Co., Ltd.K221157JR醫療設備Jr Engineering & Medical Technologies (M) Sdn. Bhd.K222449奈爾酮粉末無菌檢查手套，適用於與化療藥物及芬太尼鹽酸（深藍色）使用測試Better Care Plastic Technology Co., Ltd.K220545無粉劑氰膽素檢查手套，藍色，已測試與化療藥物使用相容Hl Rubber Industries Sdn Bhd K220491一次性醫用尼龍檢查手套 - 已測試與化療藥物使用Hainan Asther Medical Equipment Co., Ltd.

官方來源

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