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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 K212645
Device Name AT
Applicant
AT Glove Engineering SDN. BHD
No. 9, Jalan Chepor 11/7
Kawasan Perusahaan Seramik Chepor,  MY 31200
Applicant Contact L. A. Choong
Correspondent
Liberty Management Group Limited
75 Executive Drive Suite 114
Aurora,  IL  60504
Correspondent Contact Manoj Zacharias
Regulation Number880.6250
Classification Product Code
LZA  
Date Received08/20/2021
Decision Date 12/16/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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