FDA 510(k)

非无菌、單次使用、無粉檢查手套，已經過與化學治療藥物使用的測試

K 號：K171378 · 2017-09-14

決定日期2017-09-14

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, Single use, Powder-free examination glove tested for use with Chemotherapy drugs is the device name listed in this FDA 510(k) record. The listed applicant is Semperit Investments Asia Pte , Ltd.. It received FDA 510(k) clearance on 2017-09-14 under 510(k) number K171378. 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, Single use, Powder-free examination glove tested for use with Chemotherapy drugs?

Non-Sterile, Single use, Powder-free examination glove tested for use with Chemotherapy drugs is a medical device that received FDA 510(k) clearance on 2017-09-14. The listed applicant is Semperit Investments Asia Pte , Ltd.. The 510(k) number is K171378.

When did Non-Sterile, Single use, Powder-free examination glove tested for use with Chemotherapy drugs receive FDA 510(k) clearance?

Non-Sterile, Single use, Powder-free examination glove tested for use with Chemotherapy drugs received FDA 510(k) clearance on 2017-09-14, under 510(k) number K171378.

Who is the listed applicant for Non-Sterile, Single use, Powder-free examination glove tested for use with Chemotherapy drugs?

The FDA 510(k) record lists Semperit Investments Asia Pte , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Non-Sterile, Single use, Powder-free examination glove tested for use with Chemotherapy drugs?

The FDA product code for Non-Sterile, Single use, Powder-free examination glove tested for use with Chemotherapy drugs is LZA.

其他以 Semperit Investments Asia Pte , Ltd. 為申請人之記錄

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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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