FDA 510(k)

無粉体クリアビニル患者検査手袋

K番号: K171460 · 2017-09-24

申請者Shandong Zhiwei Medical Products, Co. , Ltd.

決定日2017-09-24

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 Shandong Zhiwei Medical Products, Co. , Ltd.. It received FDA 510(k) clearance on 2017-09-24 under 510(k) number K171460. 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 2017-09-24. The listed applicant is Shandong Zhiwei Medical Products, Co. , Ltd.. The 510(k) number is K171460.

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 2017-09-24, under 510(k) number K171460.

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

The FDA 510(k) record lists Shandong Zhiwei 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.

公式ソース

FDAデータベースで見る →

データはFDA Open APIから取得しています。最新かつ権威ある情報については、常に公式レコードを参照してください。

無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

関連機器（コード：LYZ）

公式ソース