FDA 510(k)

disposable medical nitrile examination gloves (non sterile)

K番号: K212639 · 2021-12-08

決定日2021-12-08

製品コードLZC

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Substantially Equivalent

医療機器の概要

Disposable Medical Nitrile Examination Gloves (Non sterile) is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Nanfang Medical Co., Ltd.. It received FDA 510(k) clearance on 2021-12-08 under 510(k) number K212639. The device is classified under product code LZC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Disposable Medical Nitrile Examination Gloves (Non sterile)?

Disposable Medical Nitrile Examination Gloves (Non sterile) is a medical device that received FDA 510(k) clearance on 2021-12-08. The listed applicant is Jiangsu Nanfang Medical Co., Ltd.. The 510(k) number is K212639.

When did Disposable Medical Nitrile Examination Gloves (Non sterile) receive FDA 510(k) clearance?

Disposable Medical Nitrile Examination Gloves (Non sterile) received FDA 510(k) clearance on 2021-12-08, under 510(k) number K212639.

Who is the listed applicant for Disposable Medical Nitrile Examination Gloves (Non sterile)?

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

What is the FDA product code for Disposable Medical Nitrile Examination Gloves (Non sterile)?

The FDA product code for Disposable Medical Nitrile Examination Gloves (Non sterile) is LZC.

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

K212826disposable medical mask

公式ソース

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