Ivory Glove Powder-Free Nitrile Examination Gloves

Polymer Patient Examination Glove

Ivory Gloves SDN. BHD.

The following data is part of a premarket notification filed by Ivory Gloves Sdn. Bhd. with the FDA for Ivory Glove Powder-free Nitrile Examination Gloves.

Pre-market Notification Details

Device IDK213681
510k NumberK213681
Device Name:Ivory Glove Powder-Free Nitrile Examination Gloves
ClassificationPolymer Patient Examination Glove
Applicant Ivory Gloves SDN. BHD. Lot 7806 Jalan Perusahaan 1, Kawasan Perindustrian Kamunting,  MY 34600
ContactArasi No Last Name Provided
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-11-22
Decision Date2022-04-21

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