Nitrile Examination Gloves

Polymer Patient Examination Glove

Emerald Glove Manufacturing Sdn Bhd

The following data is part of a premarket notification filed by Emerald Glove Manufacturing Sdn Bhd with the FDA for Nitrile Examination Gloves.

Pre-market Notification Details

Device IDK213981
510k NumberK213981
Device Name:Nitrile Examination Gloves
ClassificationPolymer Patient Examination Glove
Applicant Emerald Glove Manufacturing Sdn Bhd Lot 18912 & Lot 18911, Jalan Perusahaan 8, Kawasan Perindustrian Kamunting Taiping,  MY 834600
ContactAmran A. Aziz
CorrespondentLim Pooi Yee
Novo Quality Services Sdn Bhd Unit No 625 & 627, Block A, Kelana Centre Point, 3, Jalan SS7/19, Kelana Jaya Petaling Jaya,  MY 47301
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-20
Decision Date2022-11-12

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