FDA 510(k)

パウダーフリーのビニル患者検査手袋、クリア（無色）

K番号: K211865 · 2021-12-20

申請者Liao Ning Shangwei Medical Products Co., Ltd.

決定日2021-12-20

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

Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is the device name listed in this FDA 510(k) record. The listed applicant is Liao Ning Shangwei Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2021-12-20 under 510(k) number K211865. 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 Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)?

Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is a medical device that received FDA 510(k) clearance on 2021-12-20. The listed applicant is Liao Ning Shangwei Medical Products Co., Ltd.. The 510(k) number is K211865.

When did Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) receive FDA 510(k) clearance?

Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) received FDA 510(k) clearance on 2021-12-20, under 510(k) number K211865.

Who is the listed applicant for Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)?

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

What is the FDA product code for Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)?

The FDA product code for Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is LYZ.

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パウダーフリーのビニル患者検査手袋、クリア（無色）

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