FDA 510(k)

無菌ニトリル患者検査手袋、粉無し

K番号: K171093 · 2017-07-19

決定日2017-07-19

製品コードLZA

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

STERILE NITRILE PATIENT EXAMINATION GLOVES, POWDERFREE is the device name listed in this FDA 510(k) record. The listed applicant is Sanrea Healthcare Products Pvt, Ltd.. It received FDA 510(k) clearance on 2017-07-19 under 510(k) number K171093. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the STERILE NITRILE PATIENT EXAMINATION GLOVES, POWDERFREE?

STERILE NITRILE PATIENT EXAMINATION GLOVES, POWDERFREE is a medical device that received FDA 510(k) clearance on 2017-07-19. The listed applicant is Sanrea Healthcare Products Pvt, Ltd.. The 510(k) number is K171093.

When did STERILE NITRILE PATIENT EXAMINATION GLOVES, POWDERFREE receive FDA 510(k) clearance?

STERILE NITRILE PATIENT EXAMINATION GLOVES, POWDERFREE received FDA 510(k) clearance on 2017-07-19, under 510(k) number K171093.

Who is the listed applicant for STERILE NITRILE PATIENT EXAMINATION GLOVES, POWDERFREE?

The FDA 510(k) record lists Sanrea Healthcare Products Pvt, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERILE NITRILE PATIENT EXAMINATION GLOVES, POWDERFREE?

The FDA product code for STERILE NITRILE PATIENT EXAMINATION GLOVES, POWDERFREE is LZA.

申請者としてSanrea Healthcare Products Pvt, Ltd.を記載するその他の記録

K171550無菌ラテックス手術手袋、粉体不使用 K171367SANCARE無菌ラテックス検査手袋（GLOVTEK無菌ラテックス検査手袋としても販売されています）

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