Powder Free Nitrile Examination Gloves, Blue Chemotest

Polymer Patient Examination Glove

Careglove Global SDN. BHD.

The following data is part of a premarket notification filed by Careglove Global Sdn. Bhd. with the FDA for Powder Free Nitrile Examination Gloves, Blue Chemotest.

Pre-market Notification Details

Device IDK211666
510k NumberK211666
Device Name:Powder Free Nitrile Examination Gloves, Blue Chemotest
ClassificationPolymer Patient Examination Glove
Applicant Careglove Global SDN. BHD. Lot 17479, Lorong Senawang 2/3, Off Jalan Senawang 3, Senawang Industrial Estate Seremban,  MY 70450
ContactSiti Khatijah Ahmad
CorrespondentSiti Khatijah Ahmad
Careglove Global SDN BHD Lot 17479, Lorong Senawang 2/3, Off Jalan Senawang 3, Senewang Industrial Estate Seremban,  MY 70450
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-01
Decision Date2022-01-09

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