FDA 510(k)

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

K番号: K182382 · 2019-08-29

決定日2019-08-29

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 Examination Powder Free Glove, Aloe Vera, Blue, Nitrile Examination Powder Free Glove, Aloe Vera, Pink 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 2019-08-29 under 510(k) number K182382. 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 Examination Powder Free Glove, Aloe Vera, Blue, Nitrile Examination Powder Free Glove, Aloe Vera, Pink?

Nitrile Examination Powder Free Glove, Aloe Vera, Blue, Nitrile Examination Powder Free Glove, Aloe Vera, Pink is a medical device that received FDA 510(k) clearance on 2019-08-29. The listed applicant is Gmp Medicare Sdn Bhd (F25). The 510(k) number is K182382.

When did Nitrile Examination Powder Free Glove, Aloe Vera, Blue, Nitrile Examination Powder Free Glove, Aloe Vera, Pink receive FDA 510(k) clearance?

Nitrile Examination Powder Free Glove, Aloe Vera, Blue, Nitrile Examination Powder Free Glove, Aloe Vera, Pink received FDA 510(k) clearance on 2019-08-29, under 510(k) number K182382.

Who is the listed applicant for Nitrile Examination Powder Free Glove, Aloe Vera, Blue, Nitrile Examination Powder Free Glove, Aloe Vera, Pink?

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 Examination Powder Free Glove, Aloe Vera, Blue, Nitrile Examination Powder Free Glove, Aloe Vera, Pink?

The FDA product code for Nitrile Examination Powder Free Glove, Aloe Vera, Blue, Nitrile Examination Powder Free Glove, Aloe Vera, Pink is LZC.

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

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 K152222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

公式ソース

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