FDA 510(k)

合成ニトリル検査手袋

K番号: K212488 · 2021-11-26

決定日2021-11-26

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

Synthetic Nitrile Examination Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Shandong Hongxin Chemicals Co., Ltd.. It received FDA 510(k) clearance on 2021-11-26 under 510(k) number K212488. 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 Synthetic Nitrile Examination Gloves?

Synthetic Nitrile Examination Gloves is a medical device that received FDA 510(k) clearance on 2021-11-26. The listed applicant is Shandong Hongxin Chemicals Co., Ltd.. The 510(k) number is K212488.

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

Synthetic Nitrile Examination Gloves received FDA 510(k) clearance on 2021-11-26, under 510(k) number K212488.

Who is the listed applicant for Synthetic Nitrile Examination Gloves?

The FDA 510(k) record lists Shandong Hongxin Chemicals Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for Synthetic Nitrile Examination Gloves is LYZ.

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合成ニトリル検査手袋

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：LYZ）

公式ソース