Disposable Nitrile Medical Examination Glove (Tested For Use With Chemotherapy Drugs)

Polymer Patient Examination Glove

Siyang Threeguard Medical Supplies Co.,Ltd.

The following data is part of a premarket notification filed by Siyang Threeguard Medical Supplies Co.,ltd. with the FDA for Disposable Nitrile Medical Examination Glove (tested For Use With Chemotherapy Drugs).

Pre-market Notification Details

Device IDK212834
510k NumberK212834
Device Name:Disposable Nitrile Medical Examination Glove (Tested For Use With Chemotherapy Drugs)
ClassificationPolymer Patient Examination Glove
Applicant Siyang Threeguard Medical Supplies Co.,Ltd. East Of Nanhai Road And South Of Guilin Road, Economic Development Zone, Siyang County Suqian,  CN 223799
ContactGuo Hua
CorrespondentBoyle Wang
Shanghai Truthful Information Technology Co., Ltd. RM.1801,No.161,East Lujiazui Rd.,Pudong Shanghai,  CN 200120
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-07
Decision Date2021-12-30

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