FDA 510(k)

無菌無粉乳膠外科手套，已檢驗適合與化療藥物使用

K 號：K232444 · 2023-12-20

申請人Grand Work Plastic Products Co., Ltd.

決定日期2023-12-20

產品代碼KGO

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs is the device name listed in this FDA 510(k) record. The listed applicant is Grand Work Plastic Products Co., Ltd.. It received FDA 510(k) clearance on 2023-12-20 under 510(k) number K232444. The device is classified under product code KGO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs?

Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2023-12-20. The listed applicant is Grand Work Plastic Products Co., Ltd.. The 510(k) number is K232444.

When did Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs receive FDA 510(k) clearance?

Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs received FDA 510(k) clearance on 2023-12-20, under 510(k) number K232444.

Who is the listed applicant for Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs?

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

What is the FDA product code for Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs?

The FDA product code for Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs is KGO.

其他以 Grand Work Plastic 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。

K232039無菌無粉乳膠檢查手套（藍色），已檢驗適合與化療藥物及芬太尼鹽酸使用 K230217無菌聚異丁烯粉末無菌外科手套，已檢驗適合與化療藥物使用 K222892無粉塵聚氨酯檢查手套，藍色，已測試與化療藥物使用相容 K213574氮化丁腈膠綜合粉末無菌檢查手套（黑色）K220249無菌尼龍粉末自給檢查手套，適用於化學治療藥物及芬太尼鹽酸鹽（藍色）測試使用 K220250無菌無粉乳膠檢查手套（藍色），已檢驗可與化療藥物使用

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相關器械（代碼：KGO）

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。

官方來源

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