Medical PVC Examination Gloves

Vinyl Patient Examination Glove

Jiangxi Hongda Medical Equipment Group Ltd.

The following data is part of a premarket notification filed by Jiangxi Hongda Medical Equipment Group Ltd. with the FDA for Medical Pvc Examination Gloves.

Pre-market Notification Details

Device IDK210821
510k NumberK210821
Device Name:Medical PVC Examination Gloves
ClassificationVinyl Patient Examination Glove
Applicant Jiangxi Hongda Medical Equipment Group Ltd. 39 South Shengli Road, Jinxian County Nanchang,  CN 331700
ContactYang Qinghua
CorrespondentRay Wang
Beijing Believe-Med Technology Service Co., Ltd. Rm 912, Building #15, XiYueHui, No.5, YiHe North Rd FangShan District Beijing,  CN 102401
Product CodeLYZ  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-19
Decision Date2021-07-09

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