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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K211479
Device Name Blue Nitrile Examination Glove Powder Free
Applicant
Aspen Glove Sdn. Bhd.
Aspen House, 300, JLN Macalister,
Georgetown,  MY 10450
Applicant Contact Iskandar Basha bin Abdul Kadir
Correspondent
Liberty Management Group Ltd.
75 Executive Dr. STE 114
Aurora,  IL  60504
Correspondent Contact Manoj Zacharias
Regulation Number880.6250
Classification Product Code
LZA  
Date Received05/12/2021
Decision Date 09/16/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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