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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 K211457
Device Name Powder Free Nitrile Examination Gloves (Blue, Black, Indigo)
Applicant
Ammex Corporation
1019 W James St., Suite 200
Kent,  WA  98032
Applicant Contact Sasitharan Nair
Correspondent
Ammex Corporation
1019 W James St., Suite 200
Kent,  WA  98032
Correspondent Contact Davendran Tangaya
Regulation Number880.6250
Classification Product Code
LZA  
Date Received05/11/2021
Decision Date 12/18/2021
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
Predetermined Change
Control Plan Authorized		 No
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