FDA 510(k)

パームケアラテックス非粉体検査手袋

K番号: K202377 · 2020-12-01

決定日2020-12-01

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

Palm Care Latex Examination Powder Free Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Hi-Care Thai Gloves Co. , Ltd.. It received FDA 510(k) clearance on 2020-12-01 under 510(k) number K202377. 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 Palm Care Latex Examination Powder Free Gloves?

Palm Care Latex Examination Powder Free Gloves is a medical device that received FDA 510(k) clearance on 2020-12-01. The listed applicant is Hi-Care Thai Gloves Co. , Ltd.. The 510(k) number is K202377.

When did Palm Care Latex Examination Powder Free Gloves receive FDA 510(k) clearance?

Palm Care Latex Examination Powder Free Gloves received FDA 510(k) clearance on 2020-12-01, under 510(k) number K202377.

Who is the listed applicant for Palm Care Latex Examination Powder Free Gloves?

The FDA 510(k) record lists Hi-Care Thai Gloves Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Palm Care Latex Examination Powder Free Gloves?

The FDA product code for Palm Care Latex Examination Powder Free Gloves is LYY.

申請者としてHi-Care Thai Gloves Co. , Ltd.を記載するその他の記録

K202384パームケアブルーニトリル検査手袋ポーターフリー

公式ソース

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