FDA 510(k)

海寧硝基膠無粉病人檢查手套，藍色

K 號：K152715 · 2016-02-25

決定日期2016-02-25

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

HAINING NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR is the device name listed in this FDA 510(k) record. The listed applicant is Haining Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2016-02-25 under 510(k) number K152715. 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 HAINING NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR?

HAINING NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR is a medical device that received FDA 510(k) clearance on 2016-02-25. The listed applicant is Haining Medical Products Co., Ltd.. The 510(k) number is K152715.

When did HAINING NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR receive FDA 510(k) clearance?

HAINING NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR received FDA 510(k) clearance on 2016-02-25, under 510(k) number K152715.

Who is the listed applicant for HAINING NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR?

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

What is the FDA product code for HAINING NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR?

The FDA product code for HAINING NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR is LZA.

其他以 Haining 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。

K183068奈爾酮手套非粉白色 K182528氮化膠手套非粉黑

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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