Medical Surgical Mask (Model: ZKM-U01(non-sterilized Type 17.5cm×9.5cm))

Mask, Surgical

Guangzhou ZhengKang Medical Equipment Co.,Ltd

The following data is part of a premarket notification filed by Guangzhou Zhengkang Medical Equipment Co.,ltd with the FDA for Medical Surgical Mask (model: Zkm-u01(non-sterilized Type 17.5cm×9.5cm)).

Pre-market Notification Details

Device IDK212460
510k NumberK212460
Device Name:Medical Surgical Mask (Model: ZKM-U01(non-sterilized Type 17.5cm×9.5cm))
ClassificationMask, Surgical
Applicant Guangzhou ZhengKang Medical Equipment Co.,Ltd Room101,No.9Nanling Zhongxin Kuang Road,Taihe Town Baiyun District Guangzhou,  CN 510540
ContactMike Wu
CorrespondentTracy Che
Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90 Qianhai Road Shenzhen,  CN 518052
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-05
Decision Date2021-11-05

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