Blue Powder Free Nitrile Examination Glove With Grape Scented, Chemotherapy Drugs And Fentanyl Test Claim

Polymer Patient Examination Glove

Riverstone Resources Sdn Bhd

The following data is part of a premarket notification filed by Riverstone Resources Sdn Bhd with the FDA for Blue Powder Free Nitrile Examination Glove With Grape Scented, Chemotherapy Drugs And Fentanyl Test Claim.

Pre-market Notification Details

Device IDK220672
510k NumberK220672
Device Name:Blue Powder Free Nitrile Examination Glove With Grape Scented, Chemotherapy Drugs And Fentanyl Test Claim
ClassificationPolymer Patient Examination Glove
Applicant Riverstone Resources Sdn Bhd Lot 20852, No.119, Jalan Logam 7 Kamunting Raya Industrial Estate Taiping,  MY 34600
ContactSuresh Kumar
CorrespondentSuresh Kumar
Riverstone Resources Sdn Bhd Lot 20852, No.119, Jalan Logam 7 Kamunting Raya Industrial Estate Taiping,  MY 34600
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-07
Decision Date2022-06-03

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