FDA 510(k)

ビニル検査手袋

K番号: K213625 · 2022-02-17

申請者Dezhou Hengchang Medical Technology Co., Ltd.

決定日2022-02-17

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

Vinyl Examination Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Dezhou Hengchang Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-02-17 under 510(k) number K213625. 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 Vinyl Examination Gloves?

Vinyl Examination Gloves is a medical device that received FDA 510(k) clearance on 2022-02-17. The listed applicant is Dezhou Hengchang Medical Technology Co., Ltd.. The 510(k) number is K213625.

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

Vinyl Examination Gloves received FDA 510(k) clearance on 2022-02-17, under 510(k) number K213625.

Who is the listed applicant for Vinyl Examination Gloves?

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

What is the FDA product code for Vinyl Examination Gloves?

The FDA product code for Vinyl Examination Gloves is LYZ.

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

K220055disposable, ビニル検査手袋, ゆうろ K213634ビニル/ニトリルブレンド検査手袋

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