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FDA 510(k)

多異戊二烯無粉塵外科手術手套，適用於化學治療藥物（藍色），多異戊二烯無粉塵外科手套，適用於化學治療藥物（自然色）

K 號：K200897 · 2020-06-01

申請人Hartalega Sdn Bhd
決定日期2020-06-01
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

Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural) is the device name listed in this FDA 510(k) record. The listed applicant is Hartalega Sdn Bhd. It received FDA 510(k) clearance on 2020-06-01 under 510(k) number K200897. 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 Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural)?

Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural) is a medical device that received FDA 510(k) clearance on 2020-06-01. The listed applicant is Hartalega Sdn Bhd. The 510(k) number is K200897.

When did Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural) receive FDA 510(k) clearance?

Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural) received FDA 510(k) clearance on 2020-06-01, under 510(k) number K200897.

Who is the listed applicant for Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural)?

The FDA 510(k) record lists Hartalega Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural)?

The FDA product code for Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural) is KGO.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Hartalega Sdn Bhd 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。

K201748無蛋白質標籤的乳膠外科手套，手套每克含蛋白質量50微克或以下，並經過與化療藥物使用的測試K201531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K180645無粉塵檢查手套，含USP膠狀燕麥，並經過與化學治療藥物使用的測試 - （檸檬綠）K180786無菌尼龍粉末自給檢查手套，適用於化學治療藥物測試，藍色水（ABLU），无菌尼龍粉末自給檢查手套，適用於化學治療藥物測試，紫藍色（VBLU） - 延長袖口K173509可生物降解尼龍粉末無粉 Exam 親手套（藍色）K180644奈米粉體免洗檢查手套 - 藍檬綠色，含膠質燕麥

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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 LimitedK250313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 GmbHK240790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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