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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 K212751
Device Name Powder Free Nitrile Examination Glove
Applicant
Dainam Glove Joint Stock Company
1765a Binh Duono Ave., Hiep An Ward
Thu Dau Mot,  VN
Applicant Contact Damon Nguyen
Correspondent
Bayneto, LLC
13480 Veterans Memorial Dr., Suite F
Houston,  TX  77014
Correspondent Contact Jenny Nguyen
Regulation Number880.6250
Classification Product Code
LZA  
Date Received08/30/2021
Decision Date 09/24/2022
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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