Nitrile Powder Free Examination Gloved Tested For Use With Chemotherapy Drugs And Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested For Use With Chemotherapy Drugs And Fentanyl, Citrate (Black)

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 Nitrile Powder Free Examination Gloved Tested For Use With Chemotherapy Drugs And Fentanyl, Citrate (blue), Nitrile Powder Free Examination Glove Tested For Use With Chemotherapy Drugs And Fentanyl, Citrate (black).

Pre-market Notification Details

Device IDK200019
510k NumberK200019
Device Name:Nitrile Powder Free Examination Gloved Tested For Use With Chemotherapy Drugs And Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested For Use With Chemotherapy Drugs And Fentanyl, Citrate (Black)
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 Received2020-01-03
Decision Date2020-04-06

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00686864059462 K200019 000
20686864040839 K200019 000
20686864040716 K200019 000
20686864040709 K200019 000
20686864040693 K200019 000
20686864040686 K200019 000

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