FDA 510(k)

合成ビニル検査手袋、粉無し、黄色

K番号: K160468 · 2016-06-23

決定日2016-06-23

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

Synthetic Vinyl Examination Gloves, Powder-Free, Yellow is the device name listed in this FDA 510(k) record. The listed applicant is Inpro Technology Device Factory. It received FDA 510(k) clearance on 2016-06-23 under 510(k) number K160468. 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 Synthetic Vinyl Examination Gloves, Powder-Free, Yellow?

Synthetic Vinyl Examination Gloves, Powder-Free, Yellow is a medical device that received FDA 510(k) clearance on 2016-06-23. The listed applicant is Inpro Technology Device Factory. The 510(k) number is K160468.

When did Synthetic Vinyl Examination Gloves, Powder-Free, Yellow receive FDA 510(k) clearance?

Synthetic Vinyl Examination Gloves, Powder-Free, Yellow received FDA 510(k) clearance on 2016-06-23, under 510(k) number K160468.

Who is the listed applicant for Synthetic Vinyl Examination Gloves, Powder-Free, Yellow?

The FDA 510(k) record lists Inpro Technology Device Factory as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Synthetic Vinyl Examination Gloves, Powder-Free, Yellow?

The FDA product code for Synthetic Vinyl Examination Gloves, Powder-Free, Yellow is LYZ.

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合成ビニル検査手袋、粉無し、黄色

医療機器の概要

よくある質問

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