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FDA 510(k)

PF 硝基膽胺檢查手套，pH 鍍層，黑色-灰色與白色-黑色顏色，已測試與化療藥物及芬太尼鹽酸使用

K 號：K190466 · 2019-09-26

申請人Shen Wei USA, Inc.
決定日期2019-09-26
產品代碼LZA
諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。
決定相當於

器材摘要

PF Nitrile Exam Glove with pH coating, Black-Gray & White-Black Colors, Tested for Use with chemotheraphy drugs and Fentanyl Citrate is the device name listed in this FDA 510(k) record. The listed applicant is Shen Wei USA, Inc.. It received FDA 510(k) clearance on 2019-09-26 under 510(k) number K190466. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PF Nitrile Exam Glove with pH coating, Black-Gray & White-Black Colors, Tested for Use with chemotheraphy drugs and Fentanyl Citrate?

PF Nitrile Exam Glove with pH coating, Black-Gray & White-Black Colors, Tested for Use with chemotheraphy drugs and Fentanyl Citrate is a medical device that received FDA 510(k) clearance on 2019-09-26. The listed applicant is Shen Wei USA, Inc.. The 510(k) number is K190466.

When did PF Nitrile Exam Glove with pH coating, Black-Gray & White-Black Colors, Tested for Use with chemotheraphy drugs and Fentanyl Citrate receive FDA 510(k) clearance?

PF Nitrile Exam Glove with pH coating, Black-Gray & White-Black Colors, Tested for Use with chemotheraphy drugs and Fentanyl Citrate received FDA 510(k) clearance on 2019-09-26, under 510(k) number K190466.

Who is the listed applicant for PF Nitrile Exam Glove with pH coating, Black-Gray & White-Black Colors, Tested for Use with chemotheraphy drugs and Fentanyl Citrate?

The FDA 510(k) record lists Shen Wei USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PF Nitrile Exam Glove with pH coating, Black-Gray & White-Black Colors, Tested for Use with chemotheraphy drugs and Fentanyl Citrate?

The FDA product code for PF Nitrile Exam Glove with pH coating, Black-Gray & White-Black Colors, Tested for Use with chemotheraphy drugs and Fentanyl Citrate is LZA.

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 Shen Wei USA, Inc. 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。

K213141可生物降解無粉乳膠檢查手套，藍色和綠色，低皮膚炎潛在風險，已測試與化療藥物、芬太尼鹽酸、模擬胃酸及芬太尼鹽酸-模擬胃酸溶液使用。K213142可生物降解無粉塵 flock 纏織丁腈檢查手套，黑色和灰色，已測試與化療藥物、芬太尼鹽酸、模擬胃酸及芬太尼鹽酸模擬胃酸溶液使用。K213144可生物降解無粉塵聚氯乙烯檢查手套，藍色、綠色和白色K211620可生物降解無粉乳膠檢查手套，自然色、藍色、黑色和綠色，並標示蛋白質含量聲明（50微克或以下）K211455無粉乳膠檢查手套，含洋甘菊、橘色及橘白色K202085可生物降解無粉乳膠檢查手套，低皮膚炎潛在風險聲明，綠色

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相關器械（代碼：LZA）

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。

K261793無粉劑式尼龍檢查手套，適用於化學治療藥物及芬太尼鹽酸鹽（藍色及黑色）測試使用Maxter Healthcare, Inc.K262542可生物降解尼龍粉末免洗檢查手套，綠色；可生物降解尼龍粉末免洗檢查手套，紫藍色；經測試可與32種化學治療藥物、芬太尼及胃酸通透性抗性聲明相容Top Glove Sdn. Bhd.K260312奈米爾烯無粉塵檢查手套，藍色；經測試可用於32種化學治療藥物及芬太尼滲透阻礙聲明；奈米爾烯無粉塵檢查手套，紫藍色；經測試可用於32種化學治療藥物、西拉嗪、芬太尼及胃酸Gmp Medicare Sdn. Bhd.K261749卡迪那爾健康公司尼龍藍色檢查手套，已經通過與化學療法藥物和芬太尼鹽酸鹽的測試。CardinalhealthK260794非无菌無粉硝基膽甾醇患者檢查手套，含甘草根提取物及尿素，經測試適合與化療藥物、芬太尼鹽酸鹽、盐酸氯噻嗪及胃酸使用。海洋色Kossan International Sdn BhdK262014PUREZERO* MARIN* 硅膠無粉檢查手套；PUREZERO* MARIN-XTRA* 硅膠無粉檢查手套O&M Halyard, Inc.

官方來源

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