Non Sterile Powder Free Latex Examination Glove

Latex Patient Examination Glove

New Era Medicare Sdn. Bhd.

The following data is part of a premarket notification filed by New Era Medicare Sdn. Bhd. with the FDA for Non Sterile Powder Free Latex Examination Glove.

Pre-market Notification Details

Device IDK221667
510k NumberK221667
Device Name:Non Sterile Powder Free Latex Examination Glove
ClassificationLatex Patient Examination Glove
Applicant New Era Medicare Sdn. Bhd. Plot 2621-2624 Teluk Intan,  MY 36000
ContactFatin Nor Irdina Binti Ahmad Fauzi
CorrespondentFatin Nor Irdina Binti Ahmad Fauzi
New Era Medicare Sdn. Bhd. Plot 2621-2624 Teluk Intan,  MY 36000
Product CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-06-08
Decision Date2022-10-28

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