Latex Examination Glove, Powder Free With Protein Content Labeling Claim (50 Ug/g Or Less Of Total Extractable Protein)

Latex 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 Latex Examination Glove, Powder Free With Protein Content Labeling Claim (50 Ug/g Or Less Of Total Extractable Protein).

Pre-market Notification Details

Device IDK203705
510k NumberK203705
Device Name:Latex Examination Glove, Powder Free With Protein Content Labeling Claim (50 Ug/g Or Less Of Total Extractable Protein)
ClassificationLatex Patient Examination Glove
Applicant Careplus (M) SDN BHD Lot 120 & 121, Jalan Senawang 3, Senawang Industrial Estate Seremban,  MY 70450
ContactLim Kwee Shyan
CorrespondentLim Kwee Shyan
Careplus (M) SDN BHD Lot 120 & 121, Jalan Senawang 3, Senawang Industrial Estate Seremban,  MY 70450
Product CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-18
Decision Date2021-08-20

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