Penta Glove

Polymer Patient Examination Glove

Pentavest Holdings Sdn Bhd

The following data is part of a premarket notification filed by Pentavest Holdings Sdn Bhd with the FDA for Penta Glove.

Pre-market Notification Details

Device IDK212847
510k NumberK212847
Device Name:Penta Glove
ClassificationPolymer Patient Examination Glove
Applicant Pentavest Holdings Sdn Bhd No. 9574-9578, Jalan PTB 2 , Kawasan Perindustrian Tangga, Batu,  MY 76400
ContactTeng Boon Joo
CorrespondentManoj Zacharias
Liberty Management Group Ltd. 75 Executive Dr. STE 114 Aurora,  IL  60504
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-07
Decision Date2022-01-06

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