FDA 510(k)

Gammex® PI Plus Glove-in-Glove™ 系統已經通過測試，適合與化學治療藥物使用

K 號：K213289 · 2023-05-26

決定日期2023-05-26

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

Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs is the device name listed in this FDA 510(k) record. The listed applicant is Ansell Healthcare Products, LLC. It received FDA 510(k) clearance on 2023-05-26 under 510(k) number K213289. 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 Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs?

Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2023-05-26. The listed applicant is Ansell Healthcare Products, LLC. The 510(k) number is K213289.

When did Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs receive FDA 510(k) clearance?

Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs received FDA 510(k) clearance on 2023-05-26, under 510(k) number K213289.

Who is the listed applicant for Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs?

The FDA 510(k) record lists Ansell Healthcare Products, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs?

The FDA product code for Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs is KGO.

其他以 Ansell Healthcare Products, LLC 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。

K230079多異戊二烯外科手套，經測試適合與化療藥物使用並具有低皮膚炎潛在風險 K212148非无菌無粉多氯丙烯檢查手套（藍色）已檢驗適合與化療藥物使用 K210401Microflex 硝基膠病人檢查手套藍色款已經測試可用於化療藥物及芬太尼鹽酸鹽，Microflex 硝基膠病人檢查手套綠色款已經測試可用於化療藥物及芬太尼鹽酸鹽，Microflex 硝基膠病人檢查手套黑色款已經測試可用於化療藥物及芬太尼鹽酸鹽 K200671Microflex 硝基病人檢查手套，含洋甘菊和金合歡，藍綠粉三色，已經檢測過 K190018Gammex Non Latex PI White Polyisoprene Surgical Gloves 經測試可用於化療藥物 K182948Gammex PI雙用外科手套，已經通過與化學治療藥物的使用測試

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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。

K260558乳膠無粉外科手術手套，已經通過與化學治療藥物及芬太尼鹽酸鹽的合用測試；含膠狀燕麥粉的乳膠無粉外科手術手套，已經通過與化學治療藥物及芬太尼鹽酸鹽的合用測試Hartalega NGC Sdn. Bhd.K253060無菌乳膠無粉外科手套Protect Gloves Company Limited K250313無菌粉末釋放合成橡膠外科醫用手套，綠色，已測試與化療藥物及胃酸使用相容Harps Europe Manufacturing GmbH K240790多異戊二烯外科手套Suzhou Colour-Way New Material Co., Ltd.K232079天然橡膠乳膠外科手套，無粉，无菌，已測試與化療藥物及芬太尼（綠色）相容；天然橡膠乳膠（去膜&塗層）/（去膜&包裝）外科手套，無粉，无菌，已測試與化療藥物及芬太尼相容Wrp Asia Pacific Sdn. Bhd.K232444無菌無粉乳膠外科手套，已檢驗適合與化療藥物使用Grand Work Plastic Products Co., Ltd.

官方來源

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