FDA 510(k)

無粉白色ポリイソプレーン手術手袋-化学療法薬との使用試験済

K番号: K200915 · 2021-07-09

決定日2021-07-09

製品コードKGO

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定大幅同等

医療機器の概要

Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with The Chemotherapy Drugs is the device name listed in this FDA 510(k) record. The listed applicant is Gx Corporation Sdn Bhd. It received FDA 510(k) clearance on 2021-07-09 under 510(k) number K200915. The device is classified under product code KGO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with The Chemotherapy Drugs?

Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with The Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2021-07-09. The listed applicant is Gx Corporation Sdn Bhd. The 510(k) number is K200915.

When did Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with The Chemotherapy Drugs receive FDA 510(k) clearance?

Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with The Chemotherapy Drugs received FDA 510(k) clearance on 2021-07-09, under 510(k) number K200915.

Who is the listed applicant for Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with The Chemotherapy Drugs?

The FDA 510(k) record lists Gx Corporation Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with The Chemotherapy Drugs?

The FDA product code for Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with The Chemotherapy Drugs is KGO.

申請者としてGx Corporation Sdn Bhdを記載するその他の記録

K183354無粉体ブルーニトリル検査手袋 32種類の化学療法薬およびフェンタニルシチラートとの使用試験済み

公式ソース

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