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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 K212308
Device Name SHARK GLOVES Blue Nitrile Examination Gloves Powder Free, INCONGLOVE Blue Nitrile Examination Gloves Powder Free
Applicant
Srirungruang Global Co., Ltd.
51/7 Moo1, Mabphai
Banbung,  TH 20170
Applicant Contact Suttichai Sripradub
Correspondent
Mdi Consultants, Inc.
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Correspondent Contact Aristotle Nafpliotis
Regulation Number880.6250
Classification Product Code
LZA  
Date Received07/23/2021
Decision Date 10/29/2021
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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