Medical Disposable Face Mask Non Sterile

Mask, Surgical

Guangdong Zhong Ling Industrial Group Co., Ltd.

The following data is part of a premarket notification filed by Guangdong Zhong Ling Industrial Group Co., Ltd. with the FDA for Medical Disposable Face Mask Non Sterile.

Pre-market Notification Details

Device IDK202650
510k NumberK202650
Device Name:Medical Disposable Face Mask Non Sterile
ClassificationMask, Surgical
Applicant Guangdong Zhong Ling Industrial Group Co., Ltd. Room 101, Building 1, No. 5, Shengfeng Road Xinhe Wanjiang, Dongguan,  CN 523045
ContactAnn Ho
CorrespondentJinghua Zhou
Guangzhou Junyi Information Technology Co., Ltd. Room 215, Huaming Building, Chebei Road Guangzhou,  CN 511660
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-14
Decision Date2021-03-24

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