Glovatex™ White Latex Gloves, Glovanil™ Blue Nitrile Gloves

Latex Patient Examination Glove

Avecena Gloves Sdn Bhd

The following data is part of a premarket notification filed by Avecena Gloves Sdn Bhd with the FDA for Glovatex™ White Latex Gloves, Glovanil™ Blue Nitrile Gloves.

Pre-market Notification Details

Device IDK213775
510k NumberK213775
Device Name:Glovatex™ White Latex Gloves, Glovanil™ Blue Nitrile Gloves
ClassificationLatex Patient Examination Glove
Applicant Avecena Gloves Sdn Bhd Lot 50592 Sendayan Techvalley Bandar Sri Sendayan Seremban Negeri Sembilan,  MY 71950
ContactMohd Aswad Bin Ramli
CorrespondentMehmet Fatih Ormeci
MEDCER Uluslararasi Medikal Belgelendirme Anonim Sirketi Mevlana Bulvari No:221/141 Yildirim Kule Ankara,  TR 06830
Product CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-02
Decision Date2022-04-24

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