ENCORE Latex Ortho, Powder Free Latex Surgical Gloves With Protein Content Labeling Claim (

Surgeon's Gloves

Careplus (M) SDN BHD

The following data is part of a premarket notification filed by Careplus (m) Sdn Bhd with the FDA for Encore Latex Ortho, Powder Free Latex Surgical Gloves With Protein Content Labeling Claim (.

Pre-market Notification Details

Device IDK210656
510k NumberK210656
Device Name:ENCORE Latex Ortho, Powder Free Latex Surgical Gloves With Protein Content Labeling Claim (
ClassificationSurgeon's Gloves
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 CodeKGO  
CFR Regulation Number878.4460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-04
Decision Date2021-06-24

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