Patient Examination Gloves

Polymer Patient Examination Glove

Guang Dong Kingfa SCI. & TECH.CO., LTD.

The following data is part of a premarket notification filed by Guang Dong Kingfa Sci. & Tech.co., Ltd. with the FDA for Patient Examination Gloves.

Pre-market Notification Details

Device IDK203593
510k NumberK203593
Device Name:Patient Examination Gloves
ClassificationPolymer Patient Examination Glove
Applicant Guang Dong Kingfa SCI. & TECH.CO., LTD. No. 28 Delong Ave., Shijiao Town, Qingcheng District Qingyuan,  CN 511545
ContactXiaoge Yu
CorrespondentShelley Li
Landlink Healthcare Technology (Shanghai) Co., Ltd. Room 703, 705, Baohua International Plaza, West Guangzhong Road 555, Jingan Shanghai,  CN 200071
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-09
Decision Date2021-03-19

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