Non-Sterile, Powder Free Nitrile Exam Glove Tested For Use With Chemotherapy Drugs - Lilac, Non-Sterile, Powder Free Nitrile Exam Glove Tested For Use With Chemotherapy Drugs - Orchid, Non-Sterile, Powder Free Nitrile Exam Glove Tested For Use With C

Polymer Patient Examination Glove

Sri Trang Gloves (Thailand) Public Company Limited

The following data is part of a premarket notification filed by Sri Trang Gloves (thailand) Public Company Limited with the FDA for Non-sterile, Powder Free Nitrile Exam Glove Tested For Use With Chemotherapy Drugs - Lilac, Non-sterile, Powder Free Nitrile Exam Glove Tested For Use With Chemotherapy Drugs - Orchid, Non-sterile, Powder Free Nitrile Exam Glove Tested For Use With C.

Pre-market Notification Details

Device IDK193581
510k NumberK193581
Device Name:Non-Sterile, Powder Free Nitrile Exam Glove Tested For Use With Chemotherapy Drugs - Lilac, Non-Sterile, Powder Free Nitrile Exam Glove Tested For Use With Chemotherapy Drugs - Orchid, Non-Sterile, Powder Free Nitrile Exam Glove Tested For Use With C
ClassificationPolymer Patient Examination Glove
Applicant Sri Trang Gloves (Thailand) Public Company Limited 10 SOi 10 Phetkasem Road Hatyai,  TH 90110
ContactJarinya Jirojkul
CorrespondentJordan Smith
Sri Trang USA, Inc. 5820 West Cypress Street, Suite H Tampa,  FL  33607 -1785
Product CodeLZA  
Subsequent Product CodeLZC
Subsequent Product CodeQDO
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral Hospital
510k Review PanelGeneral Hospital
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-23
Decision Date2020-03-20

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