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FDA 510(k)

Halyard Purple Xtra 及 Purple 無菌，低皮膚炎潛在風險，無粉檢查手套，已檢測與化療藥物及芬太尼鹽酸鹽使用。

K 號：K192241 · 2020-03-13

申請人O&M Haylard, Inc.
決定日期2020-03-13
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

Halyard Purple Xtra and Purple Sterile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is the device name listed in this FDA 510(k) record. The listed applicant is O&M Haylard, Inc.. It received FDA 510(k) clearance on 2020-03-13 under 510(k) number K192241. 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 Halyard Purple Xtra and Purple Sterile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate?

Halyard Purple Xtra and Purple Sterile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is a medical device that received FDA 510(k) clearance on 2020-03-13. The listed applicant is O&M Haylard, Inc.. The 510(k) number is K192241.

When did Halyard Purple Xtra and Purple Sterile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate receive FDA 510(k) clearance?

Halyard Purple Xtra and Purple Sterile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate received FDA 510(k) clearance on 2020-03-13, under 510(k) number K192241.

Who is the listed applicant for Halyard Purple Xtra and Purple Sterile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate?

The FDA 510(k) record lists O&M Haylard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Halyard Purple Xtra and Purple Sterile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate?

The FDA product code for Halyard Purple Xtra and Purple Sterile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy 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

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.

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