FDA 510(k)

Single-use medical latex examination gloves (LG100)

K番号: K222693 · 2022-09-24

申請者Fitone Latex Products Co., Ltd. Guangdong

決定日2022-09-24

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Substantially Equivalent

医療機器の概要

Single-use medical latex examination gloves (LG100) is the device name listed in this FDA 510(k) record. The listed applicant is Fitone Latex Products Co., Ltd. Guangdong. It received FDA 510(k) clearance on 2022-09-24 under 510(k) number K222693. 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 Single-use medical latex examination gloves (LG100)?

Single-use medical latex examination gloves (LG100) is a medical device that received FDA 510(k) clearance on 2022-09-24. The listed applicant is Fitone Latex Products Co., Ltd. Guangdong. The 510(k) number is K222693.

When did Single-use medical latex examination gloves (LG100) receive FDA 510(k) clearance?

Single-use medical latex examination gloves (LG100) received FDA 510(k) clearance on 2022-09-24, under 510(k) number K222693.

Who is the listed applicant for Single-use medical latex examination gloves (LG100)?

The FDA 510(k) record lists Fitone Latex Products Co., Ltd. Guangdong as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Single-use medical latex examination gloves (LG100)?

The FDA product code for Single-use medical latex examination gloves (LG100) is LYY.

申請者としてFitone Latex Products Co., Ltd. Guangdongを記載するその他の記録

K231446Single-Use Latex Sterile Surgical Gloves (SG100)K221747Nitrile Patient Examination Gloves Tested For Use With Chemotherapy Drugs K211927Nitrile examination gloves

公式ソース

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