FDA 510(k)

ニトリルブルーポウダーフリーの検査手袋、化学療法薬との使用を検証済み

K番号: K152222 · 2016-04-21

決定日2016-04-21

製品コードLZC

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

NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy Drugs is the device name listed in this FDA 510(k) record. The listed applicant is Gmp Medicare Sdn Bhd (F25). It received FDA 510(k) clearance on 2016-04-21 under 510(k) number K152222. The device is classified under product code LZC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy Drugs?

NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy Drugs is a medical device that received FDA 510(k) clearance on 2016-04-21. The listed applicant is Gmp Medicare Sdn Bhd (F25). The 510(k) number is K152222.

When did NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy Drugs receive FDA 510(k) clearance?

NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy Drugs received FDA 510(k) clearance on 2016-04-21, under 510(k) number K152222.

Who is the listed applicant for NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy Drugs?

The FDA 510(k) record lists Gmp Medicare Sdn Bhd (F25) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy Drugs?

The FDA product code for NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy Drugs is LZC.

申請者としてGmp Medicare Sdn Bhd (F25)を記載するその他の記録

K182382ニトリル検査用粉無し手袋、アロエベラ、ブルー、ニトリル検査用粉無し手袋、アロエベラ、ピンク K172867ニトリル検査用粉無し手袋、ブラック、ニトリル検査用粉無し手袋、オレンジ

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