FDA 510(k)

Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask

K号: K211832 · 2021-09-08

申请人Zhejiang Lanhine Medical Products, Ltd.

决定日期2021-09-08

产品代码FXX

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决定实质等同

器械摘要

Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Lanhine Medical Products, Ltd.. It received FDA 510(k) clearance on 2021-09-08 under 510(k) number K211832. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask?

Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask is a medical device that received FDA 510(k) clearance on 2021-09-08. The listed applicant is Zhejiang Lanhine Medical Products, Ltd.. The 510(k) number is K211832.

When did Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask receive FDA 510(k) clearance?

Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask received FDA 510(k) clearance on 2021-09-08, under 510(k) number K211832.

Who is the listed applicant for Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask?

The FDA 510(k) record lists Zhejiang Lanhine Medical Products, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask?

The FDA product code for Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask is FXX.

列明Zhejiang Lanhine Medical Products, 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。

K211827Level 3防液体手术口罩（型号：15604F，1570F）

相关器械（代码：FXX）

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。

K251967HALYARD* FLUIDSHIELD* 3 防雾程序口罩，带有 SO SOFT* 内衬和 SO SOFT* 耳带；HALYARD* FLUIDSHIELD* 3 防雾程序口罩，带有 SO SOFT* 内衬和 SO SOFT* 耳带，带有 WrapAround 护目镜O&M Halyard, Inc.K252534Surgical Face Mask (耳挂式)Zhejiang Hangkang Medical Equipment Co., Ltd.K253398一次性手术口罩（非无菌）(EFX3PLBLKMSK300)Efofex, Inc.K252830一次性外科口罩（3P00B，C2900）Beatles Medical Supplies (Xiantao) Co., Ltd.K252650一次性医用口罩Makrite Industries, Inc.K243342KP防护口罩Kp Trading Co., Ltd.

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