FDA 510(k)

シンマックス合成患者検査用ビニルグローブ、粉なし、青

K番号: K153028 · 2016-02-05

申請者Zibo Huiying Medical Products, Co. , Ltd.

決定日2016-02-05

製品コードLYZ

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

Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue is the device name listed in this FDA 510(k) record. The listed applicant is Zibo Huiying Medical Products, Co. , Ltd.. It received FDA 510(k) clearance on 2016-02-05 under 510(k) number K153028. The device is classified under product code LYZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue?

Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue is a medical device that received FDA 510(k) clearance on 2016-02-05. The listed applicant is Zibo Huiying Medical Products, Co. , Ltd.. The 510(k) number is K153028.

When did Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue receive FDA 510(k) clearance?

Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue received FDA 510(k) clearance on 2016-02-05, under 510(k) number K153028.

Who is the listed applicant for Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue?

The FDA 510(k) record lists Zibo Huiying Medical Products, Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue?

The FDA product code for Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue is LYZ.

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シンマックス合成患者検査用ビニルグローブ、粉なし、青

医療機器の概要

よくある質問

関連する臨床試験

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