FDA 510(k)

非无菌、無粉乳膠檢查手套黑色，已測試與化療藥物使用 Compatibility

K 號：K182241 · 2019-03-11

申請人Sri Trang Gloves (Thailand) Co., Ltd.

決定日期2019-03-11

產品代碼LZA

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

Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs is the device name listed in this FDA 510(k) record. The listed applicant is Sri Trang Gloves (Thailand) Co., Ltd.. It received FDA 510(k) clearance on 2019-03-11 under 510(k) number K182241. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs?

Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2019-03-11. The listed applicant is Sri Trang Gloves (Thailand) Co., Ltd.. The 510(k) number is K182241.

When did Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs receive FDA 510(k) clearance?

Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs received FDA 510(k) clearance on 2019-03-11, under 510(k) number K182241.

Who is the listed applicant for Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs?

The FDA 510(k) record lists Sri Trang Gloves (Thailand) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs?

The FDA product code for Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs is LZA.

其他以 Sri Trang Gloves (Thailand) 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。

K182308非無菌、無粉劑氰膠檢查手套粉紅色已經測試可用於化療藥物

相關器械（代碼：LZA）

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。

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官方來源

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