FDA 510(k)

FlexGard 切り避け手袋リナー

K番号: K190782 · 2019-06-27

決定日2019-06-27

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

FlexGard Cut-Resistant Glove Liners is the device name listed in this FDA 510(k) record. The listed applicant is Ldi Corporation. It received FDA 510(k) clearance on 2019-06-27 under 510(k) number K190782. 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 FlexGard Cut-Resistant Glove Liners?

FlexGard Cut-Resistant Glove Liners is a medical device that received FDA 510(k) clearance on 2019-06-27. The listed applicant is Ldi Corporation. The 510(k) number is K190782.

When did FlexGard Cut-Resistant Glove Liners receive FDA 510(k) clearance?

FlexGard Cut-Resistant Glove Liners received FDA 510(k) clearance on 2019-06-27, under 510(k) number K190782.

Who is the listed applicant for FlexGard Cut-Resistant Glove Liners?

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

What is the FDA product code for FlexGard Cut-Resistant Glove Liners?

The FDA product code for FlexGard Cut-Resistant Glove Liners is KGO.

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FlexGard 切り避け手袋リナー

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：KGO）

公式ソース