FDA 510(k)

美林無粉光藍色丁腈檢查手套（適用於化療藥物測試）

K 號：K201390 · 2020-09-18

決定日期2020-09-18

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

Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs) is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industires, Inc.. It received FDA 510(k) clearance on 2020-09-18 under 510(k) number K201390. 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 Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs)?

Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs) is a medical device that received FDA 510(k) clearance on 2020-09-18. The listed applicant is Medline Industires, Inc.. The 510(k) number is K201390.

When did Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs) receive FDA 510(k) clearance?

Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs) received FDA 510(k) clearance on 2020-09-18, under 510(k) number K201390.

Who is the listed applicant for Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs)?

The FDA 510(k) record lists Medline Industires, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs)?

The FDA product code for Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs) is LZC.

其他以 Medline Industires, Inc. 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。

K220955Hudson RCI 變量濃度大容量霧化器 (1770)K201129美林煙霧排風筆 K200960美林無粉檢查手套（已測試與化療藥物使用）K201319Medline UNITE 騷骨折釘系統

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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