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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 K211808
Device Name Medcare Powder-Free Blue Nitrile Patient Examination Gloves
Applicant
Dongguan Grinvald Technology Co., Ltd.
401, Bldg. #3 No 4 Of Guangming New Village 2 Rd.
Dongcheng
Dongguan,  CN 52300
Applicant Contact Anna Roxana Grinvald
Correspondent
Mdi Consultants, Inc.
55 Northern Blvd.
Great Neck,  NY  11021
Correspondent Contact Aristotle Nafpliotis
Regulation Number880.6250
Classification Product Code
LZA  
Date Received06/11/2021
Decision Date 03/04/2022
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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