FDA 510(k)

ビニールガントレット

K番号: K211904 · 2021-09-17

申請者Jiangsu Dihong Industry and Trade Co., Ltd.

決定日2021-09-17

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

Vinyl Glove is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Dihong Industry and Trade Co., Ltd.. It received FDA 510(k) clearance on 2021-09-17 under 510(k) number K211904. 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 Vinyl Glove?

Vinyl Glove is a medical device that received FDA 510(k) clearance on 2021-09-17. The listed applicant is Jiangsu Dihong Industry and Trade Co., Ltd.. The 510(k) number is K211904.

When did Vinyl Glove receive FDA 510(k) clearance?

Vinyl Glove received FDA 510(k) clearance on 2021-09-17, under 510(k) number K211904.

Who is the listed applicant for Vinyl Glove?

The FDA 510(k) record lists Jiangsu Dihong Industry and Trade Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vinyl Glove?

The FDA product code for Vinyl Glove is LYZ.

申請者としてJiangsu Dihong Industry and Trade Co., Ltd.を記載するその他の記録

K211252ニトリルガント

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。