Medical Surgical Mask (Non-sterile)

Mask, Surgical

Guangdong GoodFeeling Hygiene Material Tec Co., Ltd.

The following data is part of a premarket notification filed by Guangdong Goodfeeling Hygiene Material Tec Co., Ltd. with the FDA for Medical Surgical Mask (non-sterile).

Pre-market Notification Details

Device IDK202761
510k NumberK202761
Device Name:Medical Surgical Mask (Non-sterile)
ClassificationMask, Surgical
Applicant Guangdong GoodFeeling Hygiene Material Tec Co., Ltd. No.10 Phoenix Avenue Eco-industrial Park, Danzao Town, Nanhai Foshan,  CN 528200
ContactZheng Zhijin
CorrespondentGrace Liu
Shenzhen Joyantech Consulting Co., Ltd 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen,  CN 518000
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-21
Decision Date2021-04-11

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