FDA 510(k)

外科手术服（无菌），外科手术服（非无菌）

K号: K202706 · 2020-12-31

申请人B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.

决定日期2020-12-31

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

Surgical Gown (Sterile), Surgical Gown (Non-sterile) is the device name listed in this FDA 510(k) record. The listed applicant is B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.. It received FDA 510(k) clearance on 2020-12-31 under 510(k) number K202706. 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 Surgical Gown (Sterile), Surgical Gown (Non-sterile)?

Surgical Gown (Sterile), Surgical Gown (Non-sterile) is a medical device that received FDA 510(k) clearance on 2020-12-31. The listed applicant is B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.. The 510(k) number is K202706.

When did Surgical Gown (Sterile), Surgical Gown (Non-sterile) receive FDA 510(k) clearance?

Surgical Gown (Sterile), Surgical Gown (Non-sterile) received FDA 510(k) clearance on 2020-12-31, under 510(k) number K202706.

Who is the listed applicant for Surgical Gown (Sterile), Surgical Gown (Non-sterile)?

The FDA 510(k) record lists B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Surgical Gown (Sterile), Surgical Gown (Non-sterile)?

The FDA product code for Surgical Gown (Sterile), Surgical Gown (Non-sterile) is FYA.

列明B.J.ZH.F.PANTHER MEDICAL EQUIPMENT 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。

K202843外科手术口罩（无菌），外科手术口罩（非无菌）

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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