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FDA 510(k)

無菌聚異丁烯外科無粉手套，已經通過與化學治療藥物使用的測試

K 號：K171276 · 2017-08-21

申請人Tg Medical Sdn. Bhd.
決定日期2017-08-21
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 Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy Drugs is the device name listed in this FDA 510(k) record. The listed applicant is Tg Medical Sdn. Bhd.. It received FDA 510(k) clearance on 2017-08-21 under 510(k) number K171276. 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 Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy Drugs?

Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2017-08-21. The listed applicant is Tg Medical Sdn. Bhd.. The 510(k) number is K171276.

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

Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy Drugs received FDA 510(k) clearance on 2017-08-21, under 510(k) number K171276.

Who is the listed applicant for Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy Drugs?

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

What is the FDA product code for Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy Drugs?

The FDA product code for Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy Drugs 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。

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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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