FDA 510(k)

無粉劑氰膠檢查手套（白色、藍色和黑色）已檢驗適合與化療藥物使用

K 號：K183562 · 2019-10-23

決定日期2019-10-23

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 Glove (White Colored, Blue Colored, and Black Colored) Tested for Use with Chemotherapy Drugs is the device name listed in this FDA 510(k) record. The listed applicant is Encompass Industries Sdn. Bhd.. It received FDA 510(k) clearance on 2019-10-23 under 510(k) number K183562. 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 Glove (White Colored, Blue Colored, and Black Colored) Tested for Use with Chemotherapy Drugs?

Powder-Free Nitrile Examination Glove (White Colored, Blue Colored, and Black Colored) Tested for Use with Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2019-10-23. The listed applicant is Encompass Industries Sdn. Bhd.. The 510(k) number is K183562.

When did Powder-Free Nitrile Examination Glove (White Colored, Blue Colored, and Black Colored) Tested for Use with Chemotherapy Drugs receive FDA 510(k) clearance?

Powder-Free Nitrile Examination Glove (White Colored, Blue Colored, and Black Colored) Tested for Use with Chemotherapy Drugs received FDA 510(k) clearance on 2019-10-23, under 510(k) number K183562.

Who is the listed applicant for Powder-Free Nitrile Examination Glove (White Colored, Blue Colored, and Black Colored) Tested for Use with Chemotherapy Drugs?

The FDA 510(k) record lists Encompass 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 Glove (White Colored, Blue Colored, and Black Colored) Tested for Use with Chemotherapy Drugs?

The FDA product code for Powder-Free Nitrile Examination Glove (White Colored, Blue Colored, and Black Colored) Tested for Use with Chemotherapy Drugs is LZC.

其他以 Encompass 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。

K250342無粉料多氯丙烯檢查手套（綠色）經測試適合與化療藥物及芬太尼使用 K220609無粉劑氰膠檢查手套，已檢驗可用於化學治療藥物及芬太尼（白色、藍色、黑色、橙色和綠色）

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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