FDA 510(k)

Medline Orbis 手术服

K号: K202447 · 2021-04-02

决定日期2021-04-02

产品代码FYA

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决定实质等同

器械摘要

Medline Orbis Surgical Gown is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, Inc.. It received FDA 510(k) clearance on 2021-04-02 under 510(k) number K202447. 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 Medline Orbis Surgical Gown?

Medline Orbis Surgical Gown is a medical device that received FDA 510(k) clearance on 2021-04-02. The listed applicant is Medline Industries, Inc.. The 510(k) number is K202447.

When did Medline Orbis Surgical Gown receive FDA 510(k) clearance?

Medline Orbis Surgical Gown received FDA 510(k) clearance on 2021-04-02, under 510(k) number K202447.

Who is the listed applicant for Medline Orbis Surgical Gown?

The FDA 510(k) record lists Medline Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medline Orbis Surgical Gown?

The FDA product code for Medline Orbis Surgical Gown is FYA.

列明Medline Industries, Inc.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。

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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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