FDA 510(k)

非無菌、無粉、丁腈檢查手套，藍色

K 號：K162510 · 2017-07-18

決定日期2017-07-18

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 Gloves, Blue 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 2017-07-18 under 510(k) number K162510. 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 Gloves, Blue?

Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue is a medical device that received FDA 510(k) clearance on 2017-07-18. The listed applicant is Ug Global Resources Sdn. Bhd.. The 510(k) number is K162510.

When did Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue receive FDA 510(k) clearance?

Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue received FDA 510(k) clearance on 2017-07-18, under 510(k) number K162510.

Who is the listed applicant for Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue?

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 Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue?

The FDA product code for Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue is LZA.

其他以 Ug Global Resources Sdn. Bhd. 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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官方來源

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