FDA 510(k)

ショウワ(R) 医療検査手袋（緑色）粉無し、使い捨てニトリル手袋

K番号: K190159 · 2019-05-06

決定日2019-05-06

製品コードLZC

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

Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove is the device name listed in this FDA 510(k) record. The listed applicant is Showa Best Glove, Inc.. It received FDA 510(k) clearance on 2019-05-06 under 510(k) number K190159. The device is classified under product code LZC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove?

Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove is a medical device that received FDA 510(k) clearance on 2019-05-06. The listed applicant is Showa Best Glove, Inc.. The 510(k) number is K190159.

When did Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove receive FDA 510(k) clearance?

Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove received FDA 510(k) clearance on 2019-05-06, under 510(k) number K190159.

Who is the listed applicant for Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove?

The FDA 510(k) record lists Showa Best Glove, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove?

The FDA product code for Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove is LZC.

申請者としてShowa Best Glove, Inc.を記載するその他の記録

K211003ショウア(R) ブルーニトリルポリダスティングフリー医療検査手袋 K180468SBG ブラックニトリルポリフェニルフリー医療検査手袋 K180467SBG ブルーニトリルポリフェニルフリー医療検査手袋

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。