FDA 510(k)

UniTex 非无菌、無粉、乳膠檢查手套

K 號：K161961 · 2017-05-11

決定日期2017-05-11

產品代碼LYY

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

UniTex Non-Sterile, Powder-Free, Latex Examination Glove is the device name listed in this FDA 510(k) record. The listed applicant is Ug Global Resources Sdn. Bhd.. It received FDA 510(k) clearance on 2017-05-11 under 510(k) number K161961. The device is classified under product code LYY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the UniTex Non-Sterile, Powder-Free, Latex Examination Glove?

UniTex Non-Sterile, Powder-Free, Latex Examination Glove is a medical device that received FDA 510(k) clearance on 2017-05-11. The listed applicant is Ug Global Resources Sdn. Bhd.. The 510(k) number is K161961.

When did UniTex Non-Sterile, Powder-Free, Latex Examination Glove receive FDA 510(k) clearance?

UniTex Non-Sterile, Powder-Free, Latex Examination Glove received FDA 510(k) clearance on 2017-05-11, under 510(k) number K161961.

Who is the listed applicant for UniTex Non-Sterile, Powder-Free, Latex Examination Glove?

The FDA 510(k) record lists Ug Global Resources Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UniTex Non-Sterile, Powder-Free, Latex Examination Glove?

The FDA product code for UniTex Non-Sterile, Powder-Free, Latex Examination Glove is LYY.

其他以 Ug Global Resources 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。

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相關器械（代碼：LYY）

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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