NBR Synthetic Nitrile Examination Gloves

Vinyl Patient Examination Glove

Shandong Langtai International Trade Co., Ltd.

The following data is part of a premarket notification filed by Shandong Langtai International Trade Co., Ltd. with the FDA for Nbr Synthetic Nitrile Examination Gloves.

Pre-market Notification Details

Device IDK212436
510k NumberK212436
Device Name:NBR Synthetic Nitrile Examination Gloves
ClassificationVinyl Patient Examination Glove
Applicant Shandong Langtai International Trade Co., Ltd. 8/F,office Building,Weiqiao Aluminum Deep Processing Industrial Park ,Chanshan Town,Zouping Binzhou,  CN 256206
ContactPing Wang
CorrespondentBoyle Wang
Shanghai Truthful Information Technology Co., Ltd. RM.1801,No.161,East Lujiazui Rd.,Pudong Shanghai,  CN 200120
Product CodeLYZ  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-04
Decision Date2021-12-23

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