FDA 510(k)

粉体不使用ラテックス検査手袋、ポリマーコート

K番号: K170094 · 2017-06-23

決定日2017-06-23

製品コードLYY

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

POWDER FREE LATEX EXAMINATION GLOVE, POLYMER COATED is the device name listed in this FDA 510(k) record. The listed applicant is Vietglove Corporation. It received FDA 510(k) clearance on 2017-06-23 under 510(k) number K170094. The device is classified under product code LYY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the POWDER FREE LATEX EXAMINATION GLOVE, POLYMER COATED?

POWDER FREE LATEX EXAMINATION GLOVE, POLYMER COATED is a medical device that received FDA 510(k) clearance on 2017-06-23. The listed applicant is Vietglove Corporation. The 510(k) number is K170094.

When did POWDER FREE LATEX EXAMINATION GLOVE, POLYMER COATED receive FDA 510(k) clearance?

POWDER FREE LATEX EXAMINATION GLOVE, POLYMER COATED received FDA 510(k) clearance on 2017-06-23, under 510(k) number K170094.

Who is the listed applicant for POWDER FREE LATEX EXAMINATION GLOVE, POLYMER COATED?

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

What is the FDA product code for POWDER FREE LATEX EXAMINATION GLOVE, POLYMER COATED?

The FDA product code for POWDER FREE LATEX EXAMINATION GLOVE, POLYMER COATED is LYY.

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

K201428パウダーフリーブラックニトリル検査手袋 K162175粉体不使用ラテックス検査手袋で、50ug/dm2以下のタンパク質ラベリングを主張 K153562粉体不使用のブルーニトリル検査手袋

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