FDA 510(k)

标准外科服（AAMI Level 3），加固外科服（AAMI Level 3）

K号: K210143 · 2021-07-22

决定日期2021-07-22

产品代码FYA

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决定实质等同

器械摘要

Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3) 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 2021-07-22 under 510(k) number K210143. 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 Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3)?

Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3) is a medical device that received FDA 510(k) clearance on 2021-07-22. The listed applicant is Foshan Nanhai Plus Medical Co, Ltd.. The 510(k) number is K210143.

When did Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3) receive FDA 510(k) clearance?

Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3) received FDA 510(k) clearance on 2021-07-22, under 510(k) number K210143.

Who is the listed applicant for Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3)?

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 3), Reinforced Surgical Gown (AAMI Level 3)?

The FDA product code for Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3) is FYA.

列明Foshan Nanhai Plus Medical Co, Ltd.为申报人的其他记录

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。

K222480标准外科服（AAMI Level 2）；加固外科服（AAMI Level 2）K213177Plus Medical 防护服 K211036Plus Medical 化疗病袍 K212698Plus Medical 三级隔离服 K212610Surgical Face Mask

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 Studio K252575Tuff 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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