FDA 510(k)

Goody Gloves, Wincare, TBG 手套

K 號：K213075 · 2022-01-20

決定日期2022-01-20

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

Goody Gloves, Wincare, TBG Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Thai Rubber Gloves Co., Ltd.. It received FDA 510(k) clearance on 2022-01-20 under 510(k) number K213075. 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 Goody Gloves, Wincare, TBG Gloves?

Goody Gloves, Wincare, TBG Gloves is a medical device that received FDA 510(k) clearance on 2022-01-20. The listed applicant is Thai Rubber Gloves Co., Ltd.. The 510(k) number is K213075.

When did Goody Gloves, Wincare, TBG Gloves receive FDA 510(k) clearance?

Goody Gloves, Wincare, TBG Gloves received FDA 510(k) clearance on 2022-01-20, under 510(k) number K213075.

Who is the listed applicant for Goody Gloves, Wincare, TBG Gloves?

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

What is the FDA product code for Goody Gloves, Wincare, TBG Gloves?

The FDA product code for Goody Gloves, Wincare, TBG Gloves is LZA.

其他以 Thai Rubber Gloves 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。

K213073Goody Gloves, Wincare, TBG 手套

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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