Non-Sterile, Powder-Free Nitrile Examination Glove Violet Blue Tested For Use With Chemotherapy Drugs And Fentanyl And Non-Sterile, Powder-Free Nitrile Examination Glove Blue Tested For Use With Chemotherapy Drugs And Fentanyl

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 Examination Glove Violet Blue Tested For Use With Chemotherapy Drugs And Fentanyl And Non-sterile, Powder-free Nitrile Examination Glove Blue Tested For Use With Chemotherapy Drugs And Fentanyl.

Pre-market Notification Details

Device IDK221165
510k NumberK221165
Device Name:Non-Sterile, Powder-Free Nitrile Examination Glove Violet Blue Tested For Use With Chemotherapy Drugs And Fentanyl And Non-Sterile, Powder-Free Nitrile Examination Glove Blue Tested For Use With Chemotherapy Drugs And Fentanyl
ClassificationPolymer Patient Examination Glove
Applicant Sri Trang Gloves (Thailand) Public Company Limited 110 Kanjanavanit Road Hat Yai,  TH 80230
ContactJordan Smith
CorrespondentJordan Smith
Sri Trang USA, Inc. 5820 West Cypress Street, Suite H Tampa,  FL  33607
Product CodeLZA  
Subsequent Product CodeLZC
Subsequent Product CodeOPJ
Subsequent Product CodeQDO
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-04-22
Decision Date2022-11-20

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