Synthetic Nitrile Examination Gloves

Vinyl Patient Examination Glove

Shandong Hongxin Chemicals Co., Ltd.

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

Pre-market Notification Details

Device IDK212488
510k NumberK212488
Device Name:Synthetic Nitrile Examination Gloves
ClassificationVinyl Patient Examination Glove
Applicant Shandong Hongxin Chemicals Co., Ltd. No. 10161, Xinhua Road, Zhoucun District Zibo,  CN 255399
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2021-08-09
Decision Date2021-11-26

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