免责声明: 本站汇总 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公开数据，仅供一般参考，不构成医疗建议、诊断、治疗建议或投资建议。

FDA 510(k)

一次性医用外科口罩

K号: K212097 · 2021-08-18

申请人Hebei Titans Hongsen Medical Technology Co., Ltd.
决定日期2021-08-18
产品代码FXX
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 medical surgical mask is the device name listed in this FDA 510(k) record. The listed applicant is Hebei Titans Hongsen Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-08-18 under 510(k) number K212097. 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 Disposable medical surgical mask?

Disposable medical surgical mask is a medical device that received FDA 510(k) clearance on 2021-08-18. The listed applicant is Hebei Titans Hongsen Medical Technology Co., Ltd.. The 510(k) number is K212097.

When did Disposable medical surgical mask receive FDA 510(k) clearance?

Disposable medical surgical mask received FDA 510(k) clearance on 2021-08-18, under 510(k) number K212097.

Who is the listed applicant for Disposable medical surgical mask?

The FDA 510(k) record lists Hebei Titans Hongsen Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable medical surgical mask?

The FDA product code for Disposable medical surgical mask is FXX.

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

列明Hebei Titans Hongsen Medical Technology 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。

K240361无菌无粉绿色丁腈检查手套（XS/S/M/L/XL）；无菌无粉粉色丁腈检查手套（XS/S/M/L/XL）；无菌无粉紫色丁腈检查手套（XS/S/M/L/XL）K223895一次性医用检查丁腈手套K221374一次性医用橡胶检查手套（XS/S/M/L/XL）K211229聚氯乙烯复合检查手套K182043一次性医用聚（氯乙烯）检查手套（透明，无色）K181130无菌无粉蓝色丁腈检查手套，经测试可用于化疗药物

查看所有 7 个设备 →

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.

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。

↑