Nitrile Disposable Examination Gloves

Polymer Patient Examination Glove

Xingyu Medical Tech Co., Ltd.

The following data is part of a premarket notification filed by Xingyu Medical Tech Co., Ltd. with the FDA for Nitrile Disposable Examination Gloves.

Pre-market Notification Details

Device IDK212578
510k NumberK212578
Device Name:Nitrile Disposable Examination Gloves
ClassificationPolymer Patient Examination Glove
Applicant Xingyu Medical Tech Co., Ltd. No. 2189 Yaoqian Road, Gaomi Economic Development Zone Weifang,  CN
ContactCathrine Luan
CorrespondentEva Li
Shanghai Sungo Management Consulting Company Limited Room 1309, Dongfang Building, 1500# Century Ave Shanghai,  CN 200122
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-16
Decision Date2021-12-02

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06975016721727 K212578 000
20194484320717 K212578 000
20194484320700 K212578 000
20194484320694 K212578 000
20194484320687 K212578 000
00686864061212 K212578 000
00686864061205 K212578 000
00686864061199 K212578 000
00686864061182 K212578 000
20194484320724 K212578 000
20194484320533 K212578 000
20194484320472 K212578 000
20194484320465 K212578 000
20194484320458 K212578 000
20194484320441 K212578 000
20194484320571 K212578 000
20194484320564 K212578 000
20194484320557 K212578 000
20194484320540 K212578 000
00686864061175 K212578 000

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