FDA 510(k)

医療用PVC検査手袋

K番号: K210821 · 2021-07-09

申請者Jiangxi Hongda Medical Equipment Group , Ltd.

決定日2021-07-09

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

Medical PVC Examination Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Jiangxi Hongda Medical Equipment Group , Ltd.. It received FDA 510(k) clearance on 2021-07-09 under 510(k) number K210821. 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 Medical PVC Examination Gloves?

Medical PVC Examination Gloves is a medical device that received FDA 510(k) clearance on 2021-07-09. The listed applicant is Jiangxi Hongda Medical Equipment Group , Ltd.. The 510(k) number is K210821.

When did Medical PVC Examination Gloves receive FDA 510(k) clearance?

Medical PVC Examination Gloves received FDA 510(k) clearance on 2021-07-09, under 510(k) number K210821.

Who is the listed applicant for Medical PVC Examination Gloves?

The FDA 510(k) record lists Jiangxi Hongda Medical Equipment Group , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medical PVC Examination Gloves?

The FDA product code for Medical PVC Examination Gloves is LYZ.

申請者としてJiangxi Hongda Medical Equipment Group , Ltd.を記載するその他の記録

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