Sterile Latex Surgical Gloves Powder Free

Surgeon's Gloves

Aspen Glove Sdn. Bhd.

The following data is part of a premarket notification filed by Aspen Glove Sdn. Bhd. with the FDA for Sterile Latex Surgical Gloves Powder Free.

Pre-market Notification Details

Device IDK211478
510k NumberK211478
Device Name:Sterile Latex Surgical Gloves Powder Free
ClassificationSurgeon's Gloves
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 CodeKGO  
CFR Regulation Number878.4460 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-12
Decision Date2021-09-16

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