Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested For Use With Chemotherapy Drugs, With Gastric Acid And Fentanyl Permeation Resistance Claims.

Polymer Patient Examination Glove

Central Medicare Sdn Bhd

The following data is part of a premarket notification filed by Central Medicare Sdn Bhd with the FDA for Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested For Use With Chemotherapy Drugs, With Gastric Acid And Fentanyl Permeation Resistance Claims..

Pre-market Notification Details

Device IDK211022
510k NumberK211022
Device Name:Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested For Use With Chemotherapy Drugs, With Gastric Acid And Fentanyl Permeation Resistance Claims.
ClassificationPolymer Patient Examination Glove
Applicant Central Medicare Sdn Bhd PT 2609-2620, Batu 8, Jalan Changkat Jong, Teluk Intan,  MY 36000
ContactMuhammad Abdul Rahman
CorrespondentMuhammad Abdul Rahman
Central Medicare Sdn Bhd PT 2609-2620, Batu 8, Jalan Changkat Jong, Teluk Intan,  MY 36000
Product CodeLZA  
Subsequent Product CodeLZC
Subsequent Product CodeQDO
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-05
Decision Date2021-12-22

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