FDA 510(k)

ニトリルガント・パウダーフリー・ブルー

K番号: K210145 · 2021-04-21

申請者Changzhou Universal Medical Equipment Co., Ltd.

決定日2021-04-21

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 Glove Powder Free Blue is the device name listed in this FDA 510(k) record. The listed applicant is Changzhou Universal Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2021-04-21 under 510(k) number K210145. 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 Glove Powder Free Blue?

Nitrile Glove Powder Free Blue is a medical device that received FDA 510(k) clearance on 2021-04-21. The listed applicant is Changzhou Universal Medical Equipment Co., Ltd.. The 510(k) number is K210145.

When did Nitrile Glove Powder Free Blue receive FDA 510(k) clearance?

Nitrile Glove Powder Free Blue received FDA 510(k) clearance on 2021-04-21, under 510(k) number K210145.

Who is the listed applicant for Nitrile Glove Powder Free Blue?

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

What is the FDA product code for Nitrile Glove Powder Free Blue?

The FDA product code for Nitrile Glove Powder Free Blue is LZA.

申請者としてChangzhou Universal Medical Equipment Co., Ltd.を記載するその他の記録

K213910disposable medical nitrile examination gloves - 化学療法薬との使用を検証済み K211667disposable medical synthetic nitrile examination gloves (non-sterile)

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