Biodegradable Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Blue)

Polymer Patient Examination Glove

Hartalega NGC SDN. BHD.

The following data is part of a premarket notification filed by Hartalega Ngc Sdn. Bhd. with the FDA for Biodegradable Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (blue).

Pre-market Notification Details

Device IDK200581
510k NumberK200581
Device Name:Biodegradable Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Blue)
ClassificationPolymer Patient Examination Glove
Applicant Hartalega NGC SDN. BHD. Kawasan Perindustrian Tanjung Sepang,  MY 43900
ContactKuan Mun Leong
CorrespondentNurul Aisyah Kong
Hartalega NGC SDN. BHD. Kawasan Perindustrian Tanjung Sepang,  MY 43900
Product CodeLZA  
Subsequent Product CodeLZC
Subsequent Product CodeQDO
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-05
Decision Date2020-04-25

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