FDA 510(k)

ニトリル患者検査手袋

K番号: K211012 · 2021-07-23

申請者Huayuan Medical Technology(Shangqiu) Co., Ltd.

決定日2021-07-23

製品コードLZA

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

Nitrile Patient Examination Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Huayuan Medical Technology(Shangqiu) Co., Ltd.. It received FDA 510(k) clearance on 2021-07-23 under 510(k) number K211012. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Nitrile Patient Examination Gloves?

Nitrile Patient Examination Gloves is a medical device that received FDA 510(k) clearance on 2021-07-23. The listed applicant is Huayuan Medical Technology(Shangqiu) Co., Ltd.. The 510(k) number is K211012.

When did Nitrile Patient Examination Gloves receive FDA 510(k) clearance?

Nitrile Patient Examination Gloves received FDA 510(k) clearance on 2021-07-23, under 510(k) number K211012.

Who is the listed applicant for Nitrile Patient Examination Gloves?

The FDA 510(k) record lists Huayuan Medical Technology(Shangqiu) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nitrile Patient Examination Gloves?

The FDA product code for Nitrile Patient Examination Gloves is LZA.

申請者としてHuayuan Medical Technology(Shangqiu) Co., Ltd.を記載するその他の記録

K213048ニトリル患者検査手袋（化学療法薬との使用試験済み）K211028ニトリル患者検査手袋

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。