FDA 510(k)

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

K 號：K222449 · 2022-08-27

申請人Better Care Plastic Technology Co., Ltd.

決定日期2022-08-27

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

Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue) is the device name listed in this FDA 510(k) record. The listed applicant is Better Care Plastic Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-08-27 under 510(k) number K222449. 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 Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue)?

Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue) is a medical device that received FDA 510(k) clearance on 2022-08-27. The listed applicant is Better Care Plastic Technology Co., Ltd.. The 510(k) number is K222449.

When did Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue) receive FDA 510(k) clearance?

Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue) received FDA 510(k) clearance on 2022-08-27, under 510(k) number K222449.

Who is the listed applicant for Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue)?

The FDA 510(k) record lists Better Care Plastic Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue)?

The FDA product code for Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue) is LZC.

其他以 Better Care Plastic 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。

K242533無粉劑氰膠病人檢查手套，藍色，非无菌，低皮膚炎潛在風險。已檢驗與化療藥物及芬太尼鹽酸使用。K232266無粉劑氰膠病人檢查手套，藍色，非无菌，已測試與化療藥物及芬太尼鹽酸使用 K232070可生物降解的尼龍檢查手套，經測試適合與化療藥物及芬太尼鹽酸（黑色、綠色）使用 K231567可生物降解尼龍粉末免洗檢查手套，適用於化學治療藥物、芬太尼鹽酸鹽及選擇性其他藥物（藍色）測試使用 K223713無粉乳膠檢查手套（灰色）已測試與化療藥物及芬太尼鹽酸使用 K221269無粉乳膠檢查手套（藍色），已測試與化療藥物及芬太尼鹽酸使用

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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.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.K220353廢棄醫用尼龍檢查手套-已測試與化療藥物使用相容Niujian Technology Co., Ltd.

官方來源

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