POWDER FREE NITRILE EXAMINATION GLOVE, WHITE (colored)

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, White (colored).

Pre-market Notification Details

Device IDK142858
510k NumberK142858
Device Name:POWDER FREE NITRILE EXAMINATION GLOVE, WHITE (colored)
ClassificationPolymer Patient Examination Glove
Applicant Careplus (M) SDN BHD Lot 120 & 121, Jalan Senawang 3, Senawang Industrial Estate, 70450 Seremban Negeri Sembilan Darul Khusus,  MY
ContactLim Kwee Shyan
CorrespondentLim Kwee Shyan
Careplus (M) SDN BHD Lot 120 & 121, Jalan Senawang 3, Senawang Industrial Estate, 70450 Seremban Negeri Sembilan Darul Khusus,  MY
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-10-01
Decision Date2015-02-09

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