FDA 510(k)

乙烯基複合檢驗手套

K 號：K211229 · 2021-07-29

申請人Hebei Titans Hongsen Medical Technology Co., Ltd.

決定日期2021-07-29

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

Vinyl compound examination gloves is the device name listed in this FDA 510(k) record. The listed applicant is Hebei Titans Hongsen Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-07-29 under 510(k) number K211229. 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 Vinyl compound examination gloves?

Vinyl compound examination gloves is a medical device that received FDA 510(k) clearance on 2021-07-29. The listed applicant is Hebei Titans Hongsen Medical Technology Co., Ltd.. The 510(k) number is K211229.

When did Vinyl compound examination gloves receive FDA 510(k) clearance?

Vinyl compound examination gloves received FDA 510(k) clearance on 2021-07-29, under 510(k) number K211229.

Who is the listed applicant for Vinyl compound examination gloves?

The FDA 510(k) record lists Hebei Titans Hongsen Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vinyl compound examination gloves?

The FDA product code for Vinyl compound examination gloves is LYZ.