FDA 510(k)

粉体不使用ビニル患者検査手袋

K番号: K211177 · 2021-07-17

申請者Shijiazhuang Hongjun Plastic Manufacture Co., Ltd.

決定日2021-07-17

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 is the device name listed in this FDA 510(k) record. The listed applicant is Shijiazhuang Hongjun Plastic Manufacture Co., Ltd.. It received FDA 510(k) clearance on 2021-07-17 under 510(k) number K211177. 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?

Powder Free Vinyl Patient Examination Gloves is a medical device that received FDA 510(k) clearance on 2021-07-17. The listed applicant is Shijiazhuang Hongjun Plastic Manufacture Co., Ltd.. The 510(k) number is K211177.

When did Powder Free Vinyl Patient Examination Gloves receive FDA 510(k) clearance?

Powder Free Vinyl Patient Examination Gloves received FDA 510(k) clearance on 2021-07-17, under 510(k) number K211177.

Who is the listed applicant for Powder Free Vinyl Patient Examination Gloves?

The FDA 510(k) record lists Shijiazhuang Hongjun Plastic Manufacture 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?

The FDA product code for Powder Free Vinyl Patient Examination Gloves is LYZ.

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粉体不使用ビニル患者検査手袋

医療機器の概要

よくある質問

関連する臨床試験

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