FDA 510(k)

ニトリル患者検査手袋ブルー、化学療法薬との使用試験済み、ニトリル患者検査手袋ブルー紫、化学療法薬との使用試験済み

K番号: K211220 · 2021-07-22

申請者Guangdong Kingfa Sci. & Tech.Co., Ltd.

決定日2021-07-22

製品コードLZA

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

Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Kingfa Sci. & Tech.Co., Ltd.. It received FDA 510(k) clearance on 2021-07-22 under 510(k) number K211220. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs?

Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2021-07-22. The listed applicant is Guangdong Kingfa Sci. & Tech.Co., Ltd.. The 510(k) number is K211220.

When did Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs receive FDA 510(k) clearance?

Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs received FDA 510(k) clearance on 2021-07-22, under 510(k) number K211220.

Who is the listed applicant for Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs?

The FDA 510(k) record lists Guangdong Kingfa Sci. & Tech.Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs?

The FDA product code for Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs is LZA.

申請者としてGuangdong Kingfa Sci. & Tech.Co., Ltd.を記載するその他の記録

K233723医療用外科マスク K231155バイオデグレード可能な医療用外科マスク K221983バイオデグレード可能な粉無しニトリル検査手袋、青色、バイオデグレード可能な粉無しニトリル検査手袋、青紫色、バイオデグレード可能な粉無しニトリル検査手袋、緑色 K230046ビニール検査手袋 K222612非粉体ラテックス検査手袋 K222714ニトリル患者検査手袋ブルー、化学療法薬との使用試験済み、ニトリル患者検査手袋ブルー紫、化学療法薬との使用試験済み、ニトリル患者検査手袋ブラック、化学療法薬との使用試験済み

すべての14件のデバイスを表示 →

公式ソース

FDAデータベースで見る →

データはFDA Open APIから取得しています。最新かつ権威ある情報については、常に公式レコードを参照してください。