FDA 510(k)

無粉劑氰膠檢查手套，已檢驗適合與化療藥物使用

K 號：K180476 · 2018-05-15

申請人Comfort Rubber Gloves Industries Sdn. Bhd.

決定日期2018-05-15

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

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 Comfort Rubber Gloves Industries Sdn. Bhd.. It received FDA 510(k) clearance on 2018-05-15 under 510(k) number K180476. 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 Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs?

Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2018-05-15. The listed applicant is Comfort Rubber Gloves Industries Sdn. Bhd.. The 510(k) number is K180476.

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

Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs received FDA 510(k) clearance on 2018-05-15, under 510(k) number K180476.

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

The FDA 510(k) record lists Comfort Rubber Gloves Industries Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

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

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

其他以 Comfort Rubber Gloves Industries 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。

K250069無粉天然橡膠檢查手套 – 藍色，非无菌，每平方分米50微克或以下蛋白質聲明 K240269氮化膽矽無粉檢查手套生物可降解（綠色）K241528氰化物無粉檢查手套（藍色），非无菌低皮膚炎潛在風險 K192954無電力尼龍檢查手套，已檢驗適合與化療藥物及芬太尼使用 K200181黑色無粉乳膠檢查手套，已經通過與化療藥物及芬太尼鹽酸鹽的相容性測試 K190080無粉劑氰膠檢查手套，適用於化學治療藥物使用之檢驗標籤聲明（黑色）

查看所有 9 項裝置 →

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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