Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With The Opioid Fentanyl Citrate, Simulated Gastric Acid, And Fentanyl In Gastric Acid

Polymer Patient Examination Glove

ONETEXX SDN BHD

The following data is part of a premarket notification filed by Onetexx Sdn Bhd with the FDA for Blue Nitrile Powder Free Patient Examination Glove, Non-sterile, Tested For Use With The Opioid Fentanyl Citrate, Simulated Gastric Acid, And Fentanyl In Gastric Acid.

Pre-market Notification Details

Device IDK221773
510k NumberK221773
Device Name:Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With The Opioid Fentanyl Citrate, Simulated Gastric Acid, And Fentanyl In Gastric Acid
ClassificationPolymer Patient Examination Glove
Applicant ONETEXX SDN BHD No 73-86, JLN Logam 5, Perindustrian KMNTG 3 KMNTG Raya Ind Estate Kamunting,  MY 34600
ContactFreddy Low
CorrespondentWava Truscott
Truscott MedSci Associates, LLC. 180 Burkemeade Ct. Roswell,  GA  30075
Product CodeLZA  
Subsequent Product CodeLZC
Subsequent Product CodeQDO
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-06-21
Decision Date2022-07-30

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