FDA 510(k)

無粉多氯丙烯檢查手套-粉紅色含維他命E及洋蔥精

K 號：K163041 · 2017-02-22

決定日期2017-02-22

產品代碼LZA

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

Powder Free Polychloroprene Examination Gloves-Pink with Aloe Vera and Vitamin E 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 2017-02-22 under 510(k) number K163041. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Powder Free Polychloroprene Examination Gloves-Pink with Aloe Vera and Vitamin E?

Powder Free Polychloroprene Examination Gloves-Pink with Aloe Vera and Vitamin E is a medical device that received FDA 510(k) clearance on 2017-02-22. The listed applicant is Pt. Medisafe Technologies. The 510(k) number is K163041.

When did Powder Free Polychloroprene Examination Gloves-Pink with Aloe Vera and Vitamin E receive FDA 510(k) clearance?

Powder Free Polychloroprene Examination Gloves-Pink with Aloe Vera and Vitamin E received FDA 510(k) clearance on 2017-02-22, under 510(k) number K163041.

Who is the listed applicant for Powder Free Polychloroprene Examination Gloves-Pink with Aloe Vera and Vitamin E?

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 Powder Free Polychloroprene Examination Gloves-Pink with Aloe Vera and Vitamin E?

The FDA product code for Powder Free Polychloroprene Examination Gloves-Pink with Aloe Vera and Vitamin E is LZA.

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 K173258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

相關器械（代碼：LZA）

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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官方來源

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