Powder Free Nitrile Examination Gloves, Colored (Green, Orange, Purple, White, & Black)

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, Colored (green, Orange, Purple, White, & Black).

Pre-market Notification Details

Device IDK220859
510k NumberK220859
Device Name:Powder Free Nitrile Examination Gloves, Colored (Green, Orange, Purple, White, & Black)
ClassificationPolymer Patient Examination Glove
Applicant Careglove Global SDN BHD Lot 17479, Lorong Senawang 2/3, Off Jalan Senawang 3, Senewang Industrial Estate Seremban,  MY 70450
ContactLim Kwee Shyan
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 Received2022-03-24
Decision Date2022-09-09

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