FDA 510(k)

SensiCare PI Ortho LT 外科手套（已測試與化療藥物使用）

K 號：K203538 · 2021-08-02

決定日期2021-08-02

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

SensiCare PI Ortho LT Surgical Glove (Tested for Use with Chemotherapy Drugs) is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, Inc.. It received FDA 510(k) clearance on 2021-08-02 under 510(k) number K203538. 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 SensiCare PI Ortho LT Surgical Glove (Tested for Use with Chemotherapy Drugs)?

SensiCare PI Ortho LT Surgical Glove (Tested for Use with Chemotherapy Drugs) is a medical device that received FDA 510(k) clearance on 2021-08-02. The listed applicant is Medline Industries, Inc.. The 510(k) number is K203538.

When did SensiCare PI Ortho LT Surgical Glove (Tested for Use with Chemotherapy Drugs) receive FDA 510(k) clearance?

SensiCare PI Ortho LT Surgical Glove (Tested for Use with Chemotherapy Drugs) received FDA 510(k) clearance on 2021-08-02, under 510(k) number K203538.

Who is the listed applicant for SensiCare PI Ortho LT Surgical Glove (Tested for Use with Chemotherapy Drugs)?

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

What is the FDA product code for SensiCare PI Ortho LT Surgical Glove (Tested for Use with Chemotherapy Drugs)?

The FDA product code for SensiCare PI Ortho LT Surgical Glove (Tested for Use with Chemotherapy Drugs) is KGO.

其他以 Medline Industries, 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。

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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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