FDA 510(k)

白色硝基膽矾無粉病患檢查手套，非无菌

K 號：K220427 · 2022-05-10

決定日期2022-05-10

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

White Nitrile Powder-Free Patient Examination Glove, Non Sterile is the device name listed in this FDA 510(k) record. The listed applicant is One Glove Industrial Sdn Bhd. It received FDA 510(k) clearance on 2022-05-10 under 510(k) number K220427. 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 White Nitrile Powder-Free Patient Examination Glove, Non Sterile?

White Nitrile Powder-Free Patient Examination Glove, Non Sterile is a medical device that received FDA 510(k) clearance on 2022-05-10. The listed applicant is One Glove Industrial Sdn Bhd. The 510(k) number is K220427.

When did White Nitrile Powder-Free Patient Examination Glove, Non Sterile receive FDA 510(k) clearance?

White Nitrile Powder-Free Patient Examination Glove, Non Sterile received FDA 510(k) clearance on 2022-05-10, under 510(k) number K220427.

Who is the listed applicant for White Nitrile Powder-Free Patient Examination Glove, Non Sterile?

The FDA 510(k) record lists One Glove Industrial Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for White Nitrile Powder-Free Patient Examination Glove, Non Sterile?

The FDA product code for White Nitrile Powder-Free Patient Examination Glove, Non Sterile is LZA.

其他以 One Glove Industrial 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。

K220431藍色硝基膠無粉病人檢查手套，非無菌 K220429紫羅蘭式硝基橡胶無粉病人檢查手套，非无菌 K220428黑硝基無粉塵病人檢查手套，非無菌

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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