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FDA 510(k)

一次性手术服，可拆卸加固手术服

K号: K212869 · 2021-12-13

申请人Fugou County Shenxiang Manufacturing Co., Ltd.
决定日期2021-12-13
产品代码FYA
咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同

器械摘要

Disposable Surgical Gown, Disposable Reinforced Surgical Gown is the device name listed in this FDA 510(k) record. The listed applicant is Fugou County Shenxiang Manufacturing Co., Ltd.. It received FDA 510(k) clearance on 2021-12-13 under 510(k) number K212869. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Disposable Surgical Gown, Disposable Reinforced Surgical Gown?

Disposable Surgical Gown, Disposable Reinforced Surgical Gown is a medical device that received FDA 510(k) clearance on 2021-12-13. The listed applicant is Fugou County Shenxiang Manufacturing Co., Ltd.. The 510(k) number is K212869.

When did Disposable Surgical Gown, Disposable Reinforced Surgical Gown receive FDA 510(k) clearance?

Disposable Surgical Gown, Disposable Reinforced Surgical Gown received FDA 510(k) clearance on 2021-12-13, under 510(k) number K212869.

Who is the listed applicant for Disposable Surgical Gown, Disposable Reinforced Surgical Gown?

The FDA 510(k) record lists Fugou County Shenxiang Manufacturing Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Surgical Gown, Disposable Reinforced Surgical Gown?

The FDA product code for Disposable Surgical Gown, Disposable Reinforced Surgical Gown is FYA.

相关临床试验

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

相关器械（代码：FYA）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K260407原理与意愿 ANSI/AAMI PB 70（无菌/非无菌）三级手术服（加固型）和原理与意愿 ANSI/AMMI PB70（无菌/非无菌）四级手术服/隔离服Principle & Will Co., Ltd.K261028手术服 Level2（S，M，L，XL，XXL，XXXL）Yadu Medical (Henan) Co., Ltd.K261949NYES Tuff Cuff L3 一次性隔离衣New York Embroidery StudioK252575Tuff Cuff™ 一次性手术服 AAMI L4 灭菌-大号（ML-L4-STL-DC-L）New York Embroidery Studio (NYES)K260725BAÜMER 手术服（COP01, COP04, COP05, COP10）Hindernis DE Mexico, S.A.P.I. DE C.V.K253243Cardinal Health™聚酯增强手术服Cardinal Health 200, LLC

官方来源

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