一次性外科袍 Rk-3011C
K 號：K211060 · 2022-10-28
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決定日期2022-10-28
產品代碼FYA
諮詢委員會SU
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決定相當於
器材摘要
Disposable Surgical Gown Rk-3011C is the device name listed in this FDA 510(k) record. The listed applicant is Xiantao Rhycom Non-Woven Products Co., Ltd.. It received FDA 510(k) clearance on 2022-10-28 under 510(k) number K211060. 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 Disposable Surgical Gown Rk-3011C?
Disposable Surgical Gown Rk-3011C is a medical device that received FDA 510(k) clearance on 2022-10-28. The listed applicant is Xiantao Rhycom Non-Woven Products Co., Ltd.. The 510(k) number is K211060.
When did Disposable Surgical Gown Rk-3011C receive FDA 510(k) clearance?
Disposable Surgical Gown Rk-3011C received FDA 510(k) clearance on 2022-10-28, under 510(k) number K211060.
Who is the listed applicant for Disposable Surgical Gown Rk-3011C?
The FDA 510(k) record lists Xiantao Rhycom Non-Woven Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Disposable Surgical Gown Rk-3011C?
The FDA product code for Disposable Surgical Gown Rk-3011C 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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