ZinRom Nitrile Examination Gloves

Polymer Patient Examination Glove

Changzhou Xingrong Medical Technology Co. LTD

The following data is part of a premarket notification filed by Changzhou Xingrong Medical Technology Co. Ltd with the FDA for Zinrom Nitrile Examination Gloves.

Pre-market Notification Details

Device IDK211719
510k NumberK211719
Device Name:ZinRom Nitrile Examination Gloves
ClassificationPolymer Patient Examination Glove
Applicant Changzhou Xingrong Medical Technology Co. LTD No. 528, Daqiaotou, Chaoyang Cunwei, Hengshanqiao Town, Economic Develop Changzhou,  CN 213118
ContactRay Lei
CorrespondentAmber Pang
Landlink Healthcare Technology (Shanghai) Co., Ltd. Room 1308, 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 Received2021-06-04
Decision Date2021-10-06

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