Powder Free Nitrile Examination Glove- Black, Non Sterile

Polymer Patient Examination Glove

Hong Seng Gloves Sdn Bhd

The following data is part of a premarket notification filed by Hong Seng Gloves Sdn Bhd with the FDA for Powder Free Nitrile Examination Glove- Black, Non Sterile.

Pre-market Notification Details

Device IDK212801
510k NumberK212801
Device Name:Powder Free Nitrile Examination Glove- Black, Non Sterile
ClassificationPolymer Patient Examination Glove
Applicant Hong Seng Gloves Sdn Bhd LOT 97, Jalan 10, Kawasan Perusahaan Bakar Arang Sungai Petani,  MY 08000
ContactHo Chia Yao
CorrespondentMichael Van Der Woude
Emergo Global Representative LLC 2500 Bee Cave Road, Building 1 Suite 300 Austin,  TX  78746
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-02
Decision Date2022-01-09

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