Blue Nitrile Examination Glove Powder Free

Polymer Patient Examination Glove

Aspen Glove Sdn. Bhd.

The following data is part of a premarket notification filed by Aspen Glove Sdn. Bhd. with the FDA for Blue Nitrile Examination Glove Powder Free.

Pre-market Notification Details

Device IDK211479
510k NumberK211479
Device Name:Blue Nitrile Examination Glove Powder Free
ClassificationPolymer Patient Examination Glove
Applicant Aspen Glove Sdn. Bhd. Aspen House, 300, JLN Macalister, Georgetown,  MY 10450
ContactIskandar Basha Bin Abdul Kadir
CorrespondentManoj Zacharias
Liberty Management Group Ltd. 75 Executive Dr. STE 114 Aurora,  IL  60504
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-12
Decision Date2021-09-16

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