FDA 510(k)

disposable synthetic examination gloves

K番号: K210520 · 2021-05-26

申請者Shandong Shengshixincheng Medical Science & Technology Co.,

決定日2021-05-26

製品コードLYZ

諮問委員会医療機器規制テキストの翻訳は以下の通りです。 HO [翻訳が提供されなかったため、原文の「HO」がそのまま使用されます]

決定大幅同等

医療機器の概要

Disposable Synthetic Examination Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Shandong Shengshixincheng Medical Science & Technology Co.,. It received FDA 510(k) clearance on 2021-05-26 under 510(k) number K210520. The device is classified under product code LYZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Disposable Synthetic Examination Gloves?

Disposable Synthetic Examination Gloves is a medical device that received FDA 510(k) clearance on 2021-05-26. The listed applicant is Shandong Shengshixincheng Medical Science & Technology Co.,. The 510(k) number is K210520.

When did Disposable Synthetic Examination Gloves receive FDA 510(k) clearance?

Disposable Synthetic Examination Gloves received FDA 510(k) clearance on 2021-05-26, under 510(k) number K210520.

Who is the listed applicant for Disposable Synthetic Examination Gloves?

The FDA 510(k) record lists Shandong Shengshixincheng Medical Science & Technology Co., as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Synthetic Examination Gloves?

The FDA product code for Disposable Synthetic Examination Gloves is LYZ.

申請者としてShandong Shengshixincheng Medical Science & Technology Co.,を記載するその他の記録

K210522disposable vinyl examination gloves

公式ソース

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