FDA 510(k)

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）

K番号: K182043 · 2018-09-21

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

決定日2018-09-21

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

Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) 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 2018-09-21 under 510(k) number K182043. 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 Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored)?

Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) is a medical device that received FDA 510(k) clearance on 2018-09-21. The listed applicant is Hebei Titans Hongsen Medical Technology Co., Ltd.. The 510(k) number is K182043.

When did Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) receive FDA 510(k) clearance?

Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) received FDA 510(k) clearance on 2018-09-21, under 510(k) number K182043.

Who is the listed applicant for Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored)?

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 Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored)?

The FDA product code for Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) 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 K211229Vinyl compound examination gloves 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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