FDA 510(k)

多氯丙烯無粉塵无菌外科手套，白色，已測試適合與化療使用

K 號：K173258 · 2018-04-20

決定日期2018-04-20

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

Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy is the device name listed in this FDA 510(k) record. The listed applicant is Pt. Medisafe Technologies. It received FDA 510(k) clearance on 2018-04-20 under 510(k) number K173258. 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 Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy?

Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy is a medical device that received FDA 510(k) clearance on 2018-04-20. The listed applicant is Pt. Medisafe Technologies. The 510(k) number is K173258.

When did Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy receive FDA 510(k) clearance?

Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy received FDA 510(k) clearance on 2018-04-20, under 510(k) number K173258.

Who is the listed applicant for Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy?

The FDA 510(k) record lists Pt. Medisafe Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy?

The FDA product code for Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy is KGO.

其他以 Pt. Medisafe Technologies 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。

K201774多氯丙烯粉末無菌外科手套，低皮膚炎潛在風險，並經過與化療藥物使用的測試 K182176多氯丙烯無粉塵无菌外科手套，白色，已測試與化療藥物使用 K163041無粉多氯丙烯檢查手套-粉紅色含維他命E及洋蔥精

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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