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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 K211624
Device Name USA Gloves Nitrile Powder Free Exam Gloves
Applicant
Usa Gloves
12505 Reed Rd. Suite 110
Sugar Land,  TX  77478
Applicant Contact Zishan Momin
Correspondent
Usa Gloves
12505 Reed Rd. Suite 110
Sugar Land,  TX  77478
Correspondent Contact Zishan Momin
Regulation Number880.6250
Classification Product Code
LZA  
Date Received05/27/2021
Decision Date 12/18/2021
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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