Powder Free Nitrile Examination Glove Black And Dual Color White-Blue

Polymer Patient Examination Glove

Careplus (M) SDN BHD

The following data is part of a premarket notification filed by Careplus (m) Sdn Bhd with the FDA for Powder Free Nitrile Examination Glove Black And Dual Color White-blue.

Pre-market Notification Details

Device IDK201857
510k NumberK201857
Device Name:Powder Free Nitrile Examination Glove Black And Dual Color White-Blue
ClassificationPolymer Patient Examination Glove
Applicant Careplus (M) SDN BHD Lot 120 & 121, Jalan Senawang 3, Senawang Industrial Estate Seremban,  MY 70450
ContactLim Kwee Shyan
CorrespondentBee Suan Khoo
Careplus (M) SDN BHD Lot 120 & 121, Jalan Senawang 3, Senawang Industrial Estate Seremban,  MY 70450
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-06
Decision Date2021-08-20

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