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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name surgeon's gloves
510(k) Number K211478
Device Name Sterile Latex Surgical Gloves 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 Number878.4460
Classification Product Code
KGO  
Date Received05/12/2021
Decision Date 09/16/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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