Vinyl Examination Gloves (Yellow)

Vinyl Patient Examination Glove

Xinying Trading CO., LTD.

The following data is part of a premarket notification filed by Xinying Trading Co., Ltd. with the FDA for Vinyl Examination Gloves (yellow).

Pre-market Notification Details

Device IDK203702
510k NumberK203702
Device Name:Vinyl Examination Gloves (Yellow)
ClassificationVinyl Patient Examination Glove
Applicant Xinying Trading CO., LTD. Garden Street Dezhou,  CN 253000
ContactTongguang Liu
CorrespondentBoyle Wang
Shanghai Truthful Information Technology Co., Ltd. RM.608, No.738, Shangcheng Rd., Pudong Shanghai,  CN 200120
Product CodeLYZ  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-18
Decision Date2021-02-12

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