FDA 510(k)

奈爾酮檢查無粉手套，洋蔥，藍色，奈爾酮檢查無粉手套，洋蔥，粉紅色

K 號：K182382 · 2019-08-29

決定日期2019-08-29

產品代碼LZC

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

Nitrile Examination Powder Free Glove, Aloe Vera, Blue, Nitrile Examination Powder Free Glove, Aloe Vera, Pink is the device name listed in this FDA 510(k) record. The listed applicant is Gmp Medicare Sdn Bhd (F25). It received FDA 510(k) clearance on 2019-08-29 under 510(k) number K182382. The device is classified under product code LZC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Nitrile Examination Powder Free Glove, Aloe Vera, Blue, Nitrile Examination Powder Free Glove, Aloe Vera, Pink?

Nitrile Examination Powder Free Glove, Aloe Vera, Blue, Nitrile Examination Powder Free Glove, Aloe Vera, Pink is a medical device that received FDA 510(k) clearance on 2019-08-29. The listed applicant is Gmp Medicare Sdn Bhd (F25). The 510(k) number is K182382.

When did Nitrile Examination Powder Free Glove, Aloe Vera, Blue, Nitrile Examination Powder Free Glove, Aloe Vera, Pink receive FDA 510(k) clearance?

Nitrile Examination Powder Free Glove, Aloe Vera, Blue, Nitrile Examination Powder Free Glove, Aloe Vera, Pink received FDA 510(k) clearance on 2019-08-29, under 510(k) number K182382.

Who is the listed applicant for Nitrile Examination Powder Free Glove, Aloe Vera, Blue, Nitrile Examination Powder Free Glove, Aloe Vera, Pink?

The FDA 510(k) record lists Gmp Medicare Sdn Bhd (F25) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nitrile Examination Powder Free Glove, Aloe Vera, Blue, Nitrile Examination Powder Free Glove, Aloe Vera, Pink?

The FDA product code for Nitrile Examination Powder Free Glove, Aloe Vera, Blue, Nitrile Examination Powder Free Glove, Aloe Vera, Pink is LZC.

其他以 Gmp Medicare Sdn Bhd (F25) 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。

K172867奈爾酮檢查無粉手套，黑色，奈爾酮檢查無粉手套，橙色 K152222尼龍藍粉無添加檢查手套，適用於化療藥物測試

相關器械（代碼：LZC）

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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