FDA 510(k)

卡迪那爾健康Protexis PI藍色配Neu-Thera外科手套

K 號：K201592 · 2021-09-26

決定日期2021-09-26

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

Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove is the device name listed in this FDA 510(k) record. The listed applicant is Cardinal Health200, LLC. It received FDA 510(k) clearance on 2021-09-26 under 510(k) number K201592. 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 Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove?

Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove is a medical device that received FDA 510(k) clearance on 2021-09-26. The listed applicant is Cardinal Health200, LLC. The 510(k) number is K201592.

When did Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove receive FDA 510(k) clearance?

Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove received FDA 510(k) clearance on 2021-09-26, under 510(k) number K201592.

Who is the listed applicant for Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove?

The FDA 510(k) record lists Cardinal Health200, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove?

The FDA product code for Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove is KGO.

其他以 Cardinal Health200, LLC 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。

K241780卡迪那爾健康公司硅膠檢查手套 K230838卡迪那爾健康™ 智能袍™ EDGE 通氣外科袍，配備 ASSIST™ 工具口袋 K223376Monoject Magellan 胰島素安全針筒 1mL, 31G x 6mm (8881893110)；Monoject Magellan 胰島素安全針筒 0.5mL, 31G x 6mm (8881893150)；Monoject Magellan 胰島素安全針筒 0.3mL, 31G x 6mm (8881893130)K230028肯德爾 SCD 智流控制器，卡迪納爾健康元素袖套，肯德爾 SCD 快速袖套，肯德爾 SCD 快速足環，肯德爾 SCD 逐漸壓縮舒適袖套，肯德爾 SCD 智流控制器管路組裝 K211390氰化藍無粉檢查手套 K200824卡迪那爾健康 SMARTGOWN 通氣術後袍，卡迪那爾健康 SMARTGOWN AIR 通氣術後袍

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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 Limited K250313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 GmbH K240790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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