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FDA 510(k)

無菌無粉合成橡膠外科醫用手套，皮膚過敏潛在風險低

K 號：K191860 · 2020-03-31

申請人Semperit Technische Produkte Gesellchaft M.B.H.
決定日期2020-03-31
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 Synthetic Rubber Surgeon’s Glove with Low Dermatitis Potential is the device name listed in this FDA 510(k) record. The listed applicant is Semperit Technische Produkte Gesellchaft M.B.H.. It received FDA 510(k) clearance on 2020-03-31 under 510(k) number K191860. 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 Synthetic Rubber Surgeon’s Glove with Low Dermatitis Potential?

Sterile Powder-Free Synthetic Rubber Surgeon’s Glove with Low Dermatitis Potential is a medical device that received FDA 510(k) clearance on 2020-03-31. The listed applicant is Semperit Technische Produkte Gesellchaft M.B.H.. The 510(k) number is K191860.

When did Sterile Powder-Free Synthetic Rubber Surgeon’s Glove with Low Dermatitis Potential receive FDA 510(k) clearance?

Sterile Powder-Free Synthetic Rubber Surgeon’s Glove with Low Dermatitis Potential received FDA 510(k) clearance on 2020-03-31, under 510(k) number K191860.

Who is the listed applicant for Sterile Powder-Free Synthetic Rubber Surgeon’s Glove with Low Dermatitis Potential?

The FDA 510(k) record lists Semperit Technische Produkte Gesellchaft M.B.H. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile Powder-Free Synthetic Rubber Surgeon’s Glove with Low Dermatitis Potential?

The FDA product code for Sterile Powder-Free Synthetic Rubber Surgeon’s Glove with Low Dermatitis Potential 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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