Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With Chemotherapy Drugs

Polymer Patient Examination Glove

Rimba Glove SND BHD

The following data is part of a premarket notification filed by Rimba Glove Snd Bhd with the FDA for Blue Nitrile Powder Free Patient Examination Glove, Non-sterile, Tested For Use With Chemotherapy Drugs.

Pre-market Notification Details

Device IDK212898
510k NumberK212898
Device Name:Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With Chemotherapy Drugs
ClassificationPolymer Patient Examination Glove
Applicant Rimba Glove SND BHD Plot 37, Medan Tasek, Tasek Industrial Area, Ipoh,  MY 31400
ContactZahari Bin Darus
CorrespondentMichael Van Der Woude
Emergo Global Representation LLC 2500 Bee Cave Road Bldg 1, Suite 300 Austin,  TX  78746
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-10
Decision Date2021-12-16

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