FDA 510(k)

大陽粉無しビニル患者検査手袋、透明（無色）

K番号: K162259 · 2016-12-21

決定日2016-12-21

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

DAIYANG Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is the device name listed in this FDA 510(k) record. The listed applicant is Zibo Daiyang Plastic Company. It received FDA 510(k) clearance on 2016-12-21 under 510(k) number K162259. 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 DAIYANG Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)?

DAIYANG Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is a medical device that received FDA 510(k) clearance on 2016-12-21. The listed applicant is Zibo Daiyang Plastic Company. The 510(k) number is K162259.

When did DAIYANG Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) receive FDA 510(k) clearance?

DAIYANG Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) received FDA 510(k) clearance on 2016-12-21, under 510(k) number K162259.

Who is the listed applicant for DAIYANG Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)?

The FDA 510(k) record lists Zibo Daiyang Plastic Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DAIYANG Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)?

The FDA product code for DAIYANG Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is LYZ.

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大陽粉無しビニル患者検査手袋、透明（無色）

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：LYZ）

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