無菌等級3外科袍
K 號：K211399 · 2022-07-22
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器材摘要
Sterile Level 3 Surgical Gown is the device name listed in this FDA 510(k) record. The listed applicant is Barco Tekstil Sanayi VE Ticaret A.S.. It received FDA 510(k) clearance on 2022-07-22 under 510(k) number K211399. 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 Sterile Level 3 Surgical Gown?
Sterile Level 3 Surgical Gown is a medical device that received FDA 510(k) clearance on 2022-07-22. The listed applicant is Barco Tekstil Sanayi VE Ticaret A.S.. The 510(k) number is K211399.
When did Sterile Level 3 Surgical Gown receive FDA 510(k) clearance?
Sterile Level 3 Surgical Gown received FDA 510(k) clearance on 2022-07-22, under 510(k) number K211399.
Who is the listed applicant for Sterile Level 3 Surgical Gown?
The FDA 510(k) record lists Barco Tekstil Sanayi VE Ticaret A.S. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Sterile Level 3 Surgical Gown?
The FDA product code for Sterile Level 3 Surgical Gown is FYA.
相關臨床試驗
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。
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 StudioK252575Tuff 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
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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