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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 K210463
Device Name Thermoplastic Elastomer (TPE) Hybrid Examination Glove
Applicant
Xuzhou Full Sun Medical Products , Ltd.
Bihe Industry Area, Yitang Town
Pizhou,  CN 221316
Applicant Contact Hsun-Hui Huang
Correspondent
Xuzhou Full Sun Medical Products , Ltd.
5748 Eaglewood Place
Rancho Cuamonga,  CA  91739
Correspondent Contact Elizabeth Deng
Regulation Number880.6250
Classification Product Code
LZA  
Date Received02/16/2021
Decision Date 01/23/2022
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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