FDA 510(k)

Copioumed AAMI 3 外科袍

K 號：K251860 · 2026-02-26

決定日期2026-02-26

產品代碼FYA

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Copioumed AAMI 3 Surgical Gown is the device name listed in this FDA 510(k) record. The listed applicant is Copioumed International, Inc.. It received FDA 510(k) clearance on 2026-02-26 under 510(k) number K251860. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Copioumed AAMI 3 Surgical Gown?

Copioumed AAMI 3 Surgical Gown is a medical device that received FDA 510(k) clearance on 2026-02-26. The listed applicant is Copioumed International, Inc.. The 510(k) number is K251860.

When did Copioumed AAMI 3 Surgical Gown receive FDA 510(k) clearance?

Copioumed AAMI 3 Surgical Gown received FDA 510(k) clearance on 2026-02-26, under 510(k) number K251860.

Who is the listed applicant for Copioumed AAMI 3 Surgical Gown?

The FDA 510(k) record lists Copioumed International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Copioumed AAMI 3 Surgical Gown?

The FDA product code for Copioumed AAMI 3 Surgical Gown is FYA.

其他以 Copioumed International, Inc. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K230135Copioumed 化療隔離袍

相關器械（代碼：FYA）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K260407原則與願景 ANSI/AAMI PB 70（無菌/非无菌）第3級外科袍（加強型）以及原則與願景 ANSI/AMMI PB70（無菌/非无菌）第4級外科袍/隔離袍Principle & Will Co., Ltd.K261028外科袍等級2（S，M，L，XL，XXL，XXXL）Yadu Medical (Henan) Co., Ltd.K261949NYES Tuff Cuff L3 一次性袍子New York Embroidery Studio K252575Tuff Cuff™ 一次性外科袍 AAMI L4 無菌-大號 (ML-L4-STL-DC-L)New York Embroidery Studio (NYES)K260725BAÜMER 外科袍 (COP01, COP04, COP05, COP10)Hindernis DE Mexico, S.A.P.I. DE C.V.K253243卡迪那爾健康™多層加強外科袍Cardinal Health 200, LLC

官方來源

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