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FDA 510(k)

Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid

K番号: K250313 · 2025-08-19

申請者Harps Europe Manufacturing GmbH
決定日2025-08-19
製品コードKGO
諮問委員会SU
決定Substantially Equivalent

医療機器の概要

Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid is the device name listed in this FDA 510(k) record. The listed applicant is Harps Europe Manufacturing GmbH. It received FDA 510(k) clearance on 2025-08-19 under 510(k) number K250313. 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 Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid?

Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid is a medical device that received FDA 510(k) clearance on 2025-08-19. The listed applicant is Harps Europe Manufacturing GmbH. The 510(k) number is K250313.

When did Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid receive FDA 510(k) clearance?

Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid received FDA 510(k) clearance on 2025-08-19, under 510(k) number K250313.

Who is the listed applicant for Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid?

The FDA 510(k) record lists Harps Europe Manufacturing GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid?

The FDA product code for Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid is KGO.

関連する臨床試験

関連レコードは、名称、製品コード、その他のメタデータを使用して自動的にマッチングされます。マッチは検証された臨床的、科学的、企業的、または規制上の関係を確立するものではありません。リンクされた公式情報源をご確認ください。

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関連機器（コード：KGO）

関連レコードは、名称、製品コード、その他のメタデータを使用して自動的にマッチングされます。マッチは検証された臨床的、科学的、企業的、または規制上の関係を確立するものではありません。リンクされた公式情報源をご確認ください。

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公式ソース

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