FDA 510(k)

ビニル複合検査手袋

K番号: K211229 · 2021-07-29

申請者Hebei Titans Hongsen Medical Technology Co., Ltd.

決定日2021-07-29

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 compound examination gloves is the device name listed in this FDA 510(k) record. The listed applicant is Hebei Titans Hongsen Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-07-29 under 510(k) number K211229. 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 compound examination gloves?

Vinyl compound examination gloves is a medical device that received FDA 510(k) clearance on 2021-07-29. The listed applicant is Hebei Titans Hongsen Medical Technology Co., Ltd.. The 510(k) number is K211229.

When did Vinyl compound examination gloves receive FDA 510(k) clearance?

Vinyl compound examination gloves received FDA 510(k) clearance on 2021-07-29, under 510(k) number K211229.

Who is the listed applicant for Vinyl compound examination gloves?

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

What is the FDA product code for Vinyl compound examination gloves?

The FDA product code for Vinyl compound examination gloves is LYZ.

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

K240361パウダーフリー緑色ニトリル検査手袋（XS/S/M/L/XL）；パウダーフリーピンクニトリル検査手袋（XS/S/M/L/XL）；パウダーフリー紫ニトリル検査手袋（XS/S/M/L/XL）K223895disposable 医療ニトリル検査手袋 K221374disposable medical rubber examination gloves (xs/s/m/l/xl)K212097disposable medical surgical mask K182043単回使用医療用ポリ（ビニルクロリド）検査手袋（クリア、無色）K181130無粉体ブルーニトリル検査手袋、化学療法薬との使用試験済

すべての7件のデバイスを表示 →

公式ソース

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