FDA 510(k)

無菌乙烯檢查手套，無粉

K 號：K170612 · 2017-10-23

決定日期2017-10-23

產品代碼LYZ

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

STERILE VINYL EXAMINATION GLOVES, Powder Free is the device name listed in this FDA 510(k) record. The listed applicant is Primus Gloves Pvt Limited. It received FDA 510(k) clearance on 2017-10-23 under 510(k) number K170612. The device is classified under product code LYZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the STERILE VINYL EXAMINATION GLOVES, Powder Free?

STERILE VINYL EXAMINATION GLOVES, Powder Free is a medical device that received FDA 510(k) clearance on 2017-10-23. The listed applicant is Primus Gloves Pvt Limited. The 510(k) number is K170612.

When did STERILE VINYL EXAMINATION GLOVES, Powder Free receive FDA 510(k) clearance?

STERILE VINYL EXAMINATION GLOVES, Powder Free received FDA 510(k) clearance on 2017-10-23, under 510(k) number K170612.

Who is the listed applicant for STERILE VINYL EXAMINATION GLOVES, Powder Free?

The FDA 510(k) record lists Primus Gloves Pvt Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERILE VINYL EXAMINATION GLOVES, Powder Free?

The FDA product code for STERILE VINYL EXAMINATION GLOVES, Powder Free is LYZ.

其他以 Primus Gloves Pvt Limited 為申請人之記錄

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相關器械（代碼：LYZ）

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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