SHARK GLOVES Blue Nitrile Examination Gloves Powder Free, INCONGLOVE Blue Nitrile Examination Gloves Powder Free

Polymer Patient Examination Glove

Srirungruang Global Co., LTD.

The following data is part of a premarket notification filed by Srirungruang Global Co., Ltd. with the FDA for Shark Gloves Blue Nitrile Examination Gloves Powder Free, Inconglove Blue Nitrile Examination Gloves Powder Free.

Pre-market Notification Details

Device IDK212308
510k NumberK212308
Device Name:SHARK GLOVES Blue Nitrile Examination Gloves Powder Free, INCONGLOVE Blue Nitrile Examination Gloves Powder Free
ClassificationPolymer Patient Examination Glove
Applicant Srirungruang Global Co., LTD. 51/7 Moo1, Mabphai Banbung,  TH 20170
ContactSuttichai Sripradub
CorrespondentAristotle Nafpliotis
mdi Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck,  NY  11021
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-23
Decision Date2021-10-29

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