FDA 510(k)

標準外科袍（AAMI等級2）；加強外科袍（AAMI等級2）

K 號：K222480 · 2022-11-14

決定日期2022-11-14

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

Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2) is the device name listed in this FDA 510(k) record. The listed applicant is Foshan Nanhai Plus Medical Co, Ltd.. It received FDA 510(k) clearance on 2022-11-14 under 510(k) number K222480. 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 Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2)?

Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2) is a medical device that received FDA 510(k) clearance on 2022-11-14. The listed applicant is Foshan Nanhai Plus Medical Co, Ltd.. The 510(k) number is K222480.

When did Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2) receive FDA 510(k) clearance?

Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2) received FDA 510(k) clearance on 2022-11-14, under 510(k) number K222480.

Who is the listed applicant for Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2)?

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

What is the FDA product code for Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2)?

The FDA product code for Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2) is FYA.

其他以 Foshan Nanhai Plus Medical Co, Ltd. 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。

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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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