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FDA 510(k)

尼龍無粉 Exam 手套，經測試適合與化療藥物、芬太尼鹽酸、模擬胃酸及芬太尼鹽酸中的Xylazine使用

K 號：K251716 · 2025-08-27

申請人Basic Medical Technology, Inc.
決定日期2025-08-27
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

Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate is the device name listed in this FDA 510(k) record. The listed applicant is Basic Medical Technology, Inc.. It received FDA 510(k) clearance on 2025-08-27 under 510(k) number K251716. 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 Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate?

Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate is a medical device that received FDA 510(k) clearance on 2025-08-27. The listed applicant is Basic Medical Technology, Inc.. The 510(k) number is K251716.

When did Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate receive FDA 510(k) clearance?

Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate received FDA 510(k) clearance on 2025-08-27, under 510(k) number K251716.

Who is the listed applicant for Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate?

The FDA 510(k) record lists Basic Medical Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate?

The FDA product code for Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate is LZA.

相關臨床試驗

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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。

K260860無粉合成乙烯基檢查手套（藍色、黑色）K253160辛特克斯檢驗手套K252505無粉觸感乙烯基檢查手套，透明K250193奈米粉體無粉塵檢查手套 2.8，適用於化學治療藥物、鴉片啡鹽酸鹼，模擬胃酸（淺藍色，深藍色）測試K250630氮化膽矽無粉檢查手套含玻尿酸，並經過與化學治療藥物、芬太尼鹽酸、模擬胃酸及芬太尼鹽酸中的噻唑嗪使用測試。K243792氮化膽粉無粉 Exam 手套，適用於化學治療藥物、鴉片類芬太尼鹽酸鹽（黑色、白色）測試

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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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