FDA 510(k)

disposable ヴィニル検査手袋（ピンク、ブラック、ブルー）

K番号: K222442 · 2022-09-28

申請者Anhui Bytech Medical Supplies Co., Ltd.

決定日2022-09-28

製品コードLYZ

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

DISPOSABLE VINYL EXAMINATION GLOVES (Pink, Black, Blue) is the device name listed in this FDA 510(k) record. The listed applicant is Anhui Bytech Medical Supplies Co., Ltd.. It received FDA 510(k) clearance on 2022-09-28 under 510(k) number K222442. The device is classified under product code LYZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the DISPOSABLE VINYL EXAMINATION GLOVES (Pink, Black, Blue)?

DISPOSABLE VINYL EXAMINATION GLOVES (Pink, Black, Blue) is a medical device that received FDA 510(k) clearance on 2022-09-28. The listed applicant is Anhui Bytech Medical Supplies Co., Ltd.. The 510(k) number is K222442.

When did DISPOSABLE VINYL EXAMINATION GLOVES (Pink, Black, Blue) receive FDA 510(k) clearance?

DISPOSABLE VINYL EXAMINATION GLOVES (Pink, Black, Blue) received FDA 510(k) clearance on 2022-09-28, under 510(k) number K222442.

Who is the listed applicant for DISPOSABLE VINYL EXAMINATION GLOVES (Pink, Black, Blue)?

The FDA 510(k) record lists Anhui Bytech Medical Supplies Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DISPOSABLE VINYL EXAMINATION GLOVES (Pink, Black, Blue)?

The FDA product code for DISPOSABLE VINYL EXAMINATION GLOVES (Pink, Black, Blue) is LYZ.

申請者としてAnhui Bytech Medical Supplies Co., Ltd.を記載するその他の記録

K201504単回使用医療用ポリ（ビニルクロリド）検査手袋

公式ソース

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