FDA 510(k)

Synthetic Vinyl Examination Gloves

K番号: K212002 · 2021-09-23

申請者Yunnan Huazhiyuan Medical Technology Co., Ltd.

決定日2021-09-23

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Substantially Equivalent

医療機器の概要

Synthetic Vinyl Examination Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Yunnan Huazhiyuan Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-09-23 under 510(k) number K212002. 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 Vinyl Examination Gloves?

Synthetic Vinyl Examination Gloves is a medical device that received FDA 510(k) clearance on 2021-09-23. The listed applicant is Yunnan Huazhiyuan Medical Technology Co., Ltd.. The 510(k) number is K212002.

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

Synthetic Vinyl Examination Gloves received FDA 510(k) clearance on 2021-09-23, under 510(k) number K212002.

Who is the listed applicant for Synthetic Vinyl Examination Gloves?

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

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

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

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

K213051Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs)K210686Nitrile Patient Examination Glove K210799Powder Free Vinyl Patient Examination Gloves

公式ソース

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