Medical Nitrile Examination Gloves (Power Free, Blue)

Polymer 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 Nitrile Examination Gloves (power Free, Blue).

Pre-market Notification Details

Device IDK210578
510k NumberK210578
Device Name:Medical Nitrile Examination Gloves (Power Free, Blue)
ClassificationPolymer Patient Examination Glove
Applicant Jiangxi Hongda Medical Equipment Group Ltd. 39 South Shengli RD. 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 CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-26
Decision Date2021-07-10

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