FDA 510(k)

非粉体クリアビニル患者検査手袋

K番号: K170735 · 2017-06-27

申請者Zibo Yue Fan Medical Products Co, Ltd.

決定日2017-06-27

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

Powder-Free Clear Vinyl Patient Examination Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Zibo Yue Fan Medical Products Co, Ltd.. It received FDA 510(k) clearance on 2017-06-27 under 510(k) number K170735. 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 Powder-Free Clear Vinyl Patient Examination Gloves?

Powder-Free Clear Vinyl Patient Examination Gloves is a medical device that received FDA 510(k) clearance on 2017-06-27. The listed applicant is Zibo Yue Fan Medical Products Co, Ltd.. The 510(k) number is K170735.

When did Powder-Free Clear Vinyl Patient Examination Gloves receive FDA 510(k) clearance?

Powder-Free Clear Vinyl Patient Examination Gloves received FDA 510(k) clearance on 2017-06-27, under 510(k) number K170735.

Who is the listed applicant for Powder-Free Clear Vinyl Patient Examination Gloves?

The FDA 510(k) record lists Zibo Yue Fan Medical Products Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Powder-Free Clear Vinyl Patient Examination Gloves?

The FDA product code for Powder-Free Clear Vinyl Patient Examination Gloves is LYZ.

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非粉体クリアビニル患者検査手袋

医療機器の概要

よくある質問

関連する臨床試験

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