FDA 510(k)

disposable ポリウレタンフリーヴィニール検査手袋、クリア/イエロー

K番号: K170575 · 2017-05-16

申請者Ever Global (Vietnam) Enterprise Corp

決定日2017-05-16

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 Powder Free Vinyl Exam Glove, Clear/Yellow is the device name listed in this FDA 510(k) record. The listed applicant is Ever Global (Vietnam) Enterprise Corp. It received FDA 510(k) clearance on 2017-05-16 under 510(k) number K170575. 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 Powder Free Vinyl Exam Glove, Clear/Yellow?

Disposable Powder Free Vinyl Exam Glove, Clear/Yellow is a medical device that received FDA 510(k) clearance on 2017-05-16. The listed applicant is Ever Global (Vietnam) Enterprise Corp. The 510(k) number is K170575.

When did Disposable Powder Free Vinyl Exam Glove, Clear/Yellow receive FDA 510(k) clearance?

Disposable Powder Free Vinyl Exam Glove, Clear/Yellow received FDA 510(k) clearance on 2017-05-16, under 510(k) number K170575.

Who is the listed applicant for Disposable Powder Free Vinyl Exam Glove, Clear/Yellow?

The FDA 510(k) record lists Ever Global (Vietnam) Enterprise Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Powder Free Vinyl Exam Glove, Clear/Yellow?

The FDA product code for Disposable Powder Free Vinyl Exam Glove, Clear/Yellow is LYZ.

申請者としてEver Global (Vietnam) Enterprise Corpを記載するその他の記録

K193555disposable ポリウレタン手袋、青色、化学療法薬およびフェンタニルシチル酸との使用試験済み K171422使い捨てポリニトリル検査手袋、白色/青色/黑色/ピンク色

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