FDA 510(k)

非無菌、PF 硝基膠檢查手套，已測試與化療藥物使用兼容-藍色

K 號：K182383 · 2019-03-19

決定日期2019-03-19

產品代碼LZC

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

Non-Sterile, PF Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs-Blue is the device name listed in this FDA 510(k) record. The listed applicant is Yty Industry (Manjung) Sdn Bhd. It received FDA 510(k) clearance on 2019-03-19 under 510(k) number K182383. The device is classified under product code LZC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Non-Sterile, PF Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs-Blue?

Non-Sterile, PF Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs-Blue is a medical device that received FDA 510(k) clearance on 2019-03-19. The listed applicant is Yty Industry (Manjung) Sdn Bhd. The 510(k) number is K182383.

When did Non-Sterile, PF Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs-Blue receive FDA 510(k) clearance?

Non-Sterile, PF Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs-Blue received FDA 510(k) clearance on 2019-03-19, under 510(k) number K182383.

Who is the listed applicant for Non-Sterile, PF Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs-Blue?

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

What is the FDA product code for Non-Sterile, PF Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs-Blue?

The FDA product code for Non-Sterile, PF Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs-Blue is LZC.

其他以 Yty Industry (Manjung) Sdn Bhd 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。

K220644非无菌、無粉、雙手適用、有紋理、珠狀袖口、一次性使用，Doffy® 硝基化學檢查手套，已檢驗可與化學治療藥物使用 K202536非无菌、無粉乳膠檢查手套，低皮膚炎潛在風險，已檢驗適合與化療藥物使用，以及非无菌、無粉乳膠檢查手套，已檢驗適合與化療藥物及芬太尼鹽酸使用。K200453非无菌、無粉乳膠檢查手套，低皮膚炎潛在風險，並經過與化療藥物使用的測試藍-AC K171104非無菌、無粉劑氰膠檢查手套，已測試與化療藥物使用相容（藍色、钴藍色）K162095非无菌、無粉乳膠檢查手套，適用於化學治療藥物測試（原藍色、钴藍色）

相關器械（代碼：LZC）

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。

K252313卡迪那爾健康公司硅膠檢查手套長袖Cardinalhealth K243959無粉劑氰膠檢查手套（紫、黑、綠），已檢驗可與化療藥物、芬太尼鹽酸鹽及選擇其他藥物使用Lingshi Hongruida Health Protection Technology Co., Ltd.K221157JR醫療設備Jr Engineering & Medical Technologies (M) Sdn. Bhd.K222449奈爾酮粉末無菌檢查手套，適用於與化療藥物及芬太尼鹽酸（深藍色）使用測試Better Care Plastic Technology Co., Ltd.K220545無粉劑氰膽素檢查手套，藍色，已測試與化療藥物使用相容Hl Rubber Industries Sdn Bhd K220491一次性醫用尼龍檢查手套 - 已測試與化療藥物使用Hainan Asther Medical Equipment Co., Ltd.

官方來源

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