FDA 510(k)

永昌粉無しイエローヴィニル患者検査手袋

K番号: K152818 · 2016-05-26

決定日2016-05-26

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

Yongchang Powder-Free Yellow Vinyl Patient Examination Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Ideal Plastic Co., Ltd.. It received FDA 510(k) clearance on 2016-05-26 under 510(k) number K152818. 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 Yongchang Powder-Free Yellow Vinyl Patient Examination Gloves?

Yongchang Powder-Free Yellow Vinyl Patient Examination Gloves is a medical device that received FDA 510(k) clearance on 2016-05-26. The listed applicant is Ideal Plastic Co., Ltd.. The 510(k) number is K152818.

When did Yongchang Powder-Free Yellow Vinyl Patient Examination Gloves receive FDA 510(k) clearance?

Yongchang Powder-Free Yellow Vinyl Patient Examination Gloves received FDA 510(k) clearance on 2016-05-26, under 510(k) number K152818.

Who is the listed applicant for Yongchang Powder-Free Yellow Vinyl Patient Examination Gloves?

The FDA 510(k) record lists Ideal Plastic Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Yongchang Powder-Free Yellow Vinyl Patient Examination Gloves?

The FDA product code for Yongchang Powder-Free Yellow Vinyl Patient Examination Gloves is LYZ.

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永昌粉無しイエローヴィニル患者検査手袋

医療機器の概要

よくある質問

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