FDA 510(k)

ラテックスフリーポリマーコート検査手袋で、手袋1グラムあたり50マイクログラム以下のタンパク質ラベルの主張

K番号: K161006 · 2016-08-04

決定日2016-08-04

製品コードLYY

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

Latex Powder Free Polymer Coated Examination Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove is the device name listed in this FDA 510(k) record. The listed applicant is Hartalega Sdn Bhd. It received FDA 510(k) clearance on 2016-08-04 under 510(k) number K161006. The device is classified under product code LYY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Latex Powder Free Polymer Coated Examination Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove?

Latex Powder Free Polymer Coated Examination Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove is a medical device that received FDA 510(k) clearance on 2016-08-04. The listed applicant is Hartalega Sdn Bhd. The 510(k) number is K161006.

When did Latex Powder Free Polymer Coated Examination Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove receive FDA 510(k) clearance?

Latex Powder Free Polymer Coated Examination Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove received FDA 510(k) clearance on 2016-08-04, under 510(k) number K161006.

Who is the listed applicant for Latex Powder Free Polymer Coated Examination Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove?

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

What is the FDA product code for Latex Powder Free Polymer Coated Examination Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove?

The FDA product code for Latex Powder Free Polymer Coated Examination Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove is LYY.