FDA 510(k)

無粉白色のゴム製検査手袋

K番号: K161072 · 2016-07-14

決定日2016-07-14

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 Grey Vinyl Examination Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Zibo Flourish Trading Co., Ltd.. It received FDA 510(k) clearance on 2016-07-14 under 510(k) number K161072. 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 Grey Vinyl Examination Gloves?

Powder Free Grey Vinyl Examination Gloves is a medical device that received FDA 510(k) clearance on 2016-07-14. The listed applicant is Zibo Flourish Trading Co., Ltd.. The 510(k) number is K161072.

When did Powder Free Grey Vinyl Examination Gloves receive FDA 510(k) clearance?

Powder Free Grey Vinyl Examination Gloves received FDA 510(k) clearance on 2016-07-14, under 510(k) number K161072.

Who is the listed applicant for Powder Free Grey Vinyl Examination Gloves?

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

What is the FDA product code for Powder Free Grey Vinyl Examination Gloves?

The FDA product code for Powder Free Grey Vinyl Examination Gloves is LYZ.

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無粉白色のゴム製検査手袋

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：LYZ）

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