PP Care Nitrile Examination Gloves

Polymer Patient Examination Glove

EG Group Product And Services CO., Ltd

The following data is part of a premarket notification filed by Eg Group Product And Services Co., Ltd with the FDA for Pp Care Nitrile Examination Gloves.

Pre-market Notification Details

Device IDK212629
510k NumberK212629
Device Name:PP Care Nitrile Examination Gloves
ClassificationPolymer Patient Examination Glove
Applicant EG Group Product And Services CO., Ltd 168/72 Nakniwat Road, Lat Phrao Bangkok,  TH 10230
ContactAristotle Nafpliotis
CorrespondentTim Kania
MDI Consultants Inc. 55 Northen Blvd, Suite 200 Great Neck,  NY  11021
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-19
Decision Date2022-05-26

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