Power Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs And Fentanyl

Polymer Patient Examination Glove

Comfort Rubber Gloves Industries Sdn. Bhd.

The following data is part of a premarket notification filed by Comfort Rubber Gloves Industries Sdn. Bhd. with the FDA for Power Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs And Fentanyl.

Pre-market Notification Details

Device IDK192954
510k NumberK192954
Device Name:Power Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs And Fentanyl
ClassificationPolymer Patient Examination Glove
Applicant Comfort Rubber Gloves Industries Sdn. Bhd. Lot 821, Jalan Matang Matang,  MY 34750
ContactNg Kok Howe
CorrespondentNg Kok Howe
Comfort Rubber Gloves Industries Sdn. Bhd. Lot 821, Jalan Matang Matang,  MY 34750
Product CodeLZA  
Subsequent Product CodeLZC
Subsequent Product CodeQDO
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-21
Decision Date2020-06-19

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