FDA 510(k)

卡迪那爾健康無粉塵聚異丁烯醫用外科手術手套，具有水凝胶塗層

K 號：K160875 · 2016-07-11

決定日期2016-07-11

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 Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating is the device name listed in this FDA 510(k) record. The listed applicant is Cardinal Health, Inc.. It received FDA 510(k) clearance on 2016-07-11 under 510(k) number K160875. 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 Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating?

Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating is a medical device that received FDA 510(k) clearance on 2016-07-11. The listed applicant is Cardinal Health, Inc.. The 510(k) number is K160875.

When did Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating receive FDA 510(k) clearance?

Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating received FDA 510(k) clearance on 2016-07-11, under 510(k) number K160875.

Who is the listed applicant for Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating?

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

What is the FDA product code for Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating?

The FDA product code for Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating is KGO.

其他以 Cardinal Health, 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。

K170198卡迪那爾健康無粉塵聚異丁烯混合粉末外科手套，適用於化學治療藥物測試（白色）K160411卡迪那爾健康公司膠質無粉檢查手套，配備Neu-thera塗層 K153316Cardinal Health 無粉乳膠外科手套，配硝基膠塗層，並經過化學治療藥物使用測試（黃色）

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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