FDA 510(k)

HG Pro 硅膠無粉檢查手套

K 號：K152479 · 2016-04-04

決定日期2016-04-04

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

HG Pro Nitrile Powder Free Examination Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Healthy Glove Co., Ltd.. It received FDA 510(k) clearance on 2016-04-04 under 510(k) number K152479. 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 HG Pro Nitrile Powder Free Examination Gloves?

HG Pro Nitrile Powder Free Examination Gloves is a medical device that received FDA 510(k) clearance on 2016-04-04. The listed applicant is Healthy Glove Co., Ltd.. The 510(k) number is K152479.

When did HG Pro Nitrile Powder Free Examination Gloves receive FDA 510(k) clearance?

HG Pro Nitrile Powder Free Examination Gloves received FDA 510(k) clearance on 2016-04-04, under 510(k) number K152479.

Who is the listed applicant for HG Pro Nitrile Powder Free Examination Gloves?

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

What is the FDA product code for HG Pro Nitrile Powder Free Examination Gloves?

The FDA product code for HG Pro Nitrile Powder Free Examination Gloves is LZA.

其他以 Healthy Glove 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。

K162381HG PRO XP 硅膠無粉檢查手套，已經通過與化學治療藥物使用的測試

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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