Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)

Vinyl Patient Examination Glove

Anhui Powerguard Technology Co.,Ltd

The following data is part of a premarket notification filed by Anhui Powerguard Technology Co.,ltd with the FDA for Powder Free Vinyl Patient Examination Gloves, Clear (non-colored).

Pre-market Notification Details

Device IDK191292
501k NumberK191292
Device Name:Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
ClassificationVinyl Patient Examination Glove
Applicant Anhui Powerguard Technology Co.,Ltd North Development Zone, Lingbi County Jiujiang,  CN 234200
ContactNike Dai
CorrespondentChu Xiaoan
Beijing Easylink CO., LTD Rm. F302 Bldg., 41, Jing Cheng Ya Ju Courtyard 6 Of Southern Dou Ge Zhuang Beijing,  CN 100021
Product CodeLYZ  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral Hospital
501k Review PanelGeneral Hospital
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-05-14
Decision Date2019-11-05

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