FDA 510(k)

基本辛格衛尼龍檢查手套，無粉，藍色，非無菌

K 號：K231408 · 2023-08-11

申請人Shandong Intco Medical Products Co, Ltd.

決定日期2023-08-11

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

Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile is the device name listed in this FDA 510(k) record. The listed applicant is Shandong Intco Medical Products Co, Ltd.. It received FDA 510(k) clearance on 2023-08-11 under 510(k) number K231408. 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 Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile?

Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile is a medical device that received FDA 510(k) clearance on 2023-08-11. The listed applicant is Shandong Intco Medical Products Co, Ltd.. The 510(k) number is K231408.

When did Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile receive FDA 510(k) clearance?

Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile received FDA 510(k) clearance on 2023-08-11, under 510(k) number K231408.

Who is the listed applicant for Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile?

The FDA 510(k) record lists Shandong Intco Medical Products Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile?

The FDA product code for Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile is LZA.

其他以 Shandong Intco Medical Products 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。

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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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