FDA 510(k)

Kindguard ポリエステルフリーヴィニル患者検査手袋、クリア（無色）

K番号: K173017 · 2017-12-15

申請者Anhui Kindguard Medical Supplies Technology Co., Ltd.

決定日2017-12-15

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

Kindguard Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is the device name listed in this FDA 510(k) record. The listed applicant is Anhui Kindguard Medical Supplies Technology Co., Ltd.. It received FDA 510(k) clearance on 2017-12-15 under 510(k) number K173017. 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 Kindguard Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)?

Kindguard Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is a medical device that received FDA 510(k) clearance on 2017-12-15. The listed applicant is Anhui Kindguard Medical Supplies Technology Co., Ltd.. The 510(k) number is K173017.

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

Kindguard Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) received FDA 510(k) clearance on 2017-12-15, under 510(k) number K173017.

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

The FDA 510(k) record lists Anhui Kindguard Medical Supplies Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

申請者としてAnhui Kindguard Medical Supplies Technology Co., Ltd.を記載するその他の記録

K223281disposable ニトリル検査手袋 K173016Kindguard ポリエステルフリーヴィニル患者検査手袋、明るい黄色色

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