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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vinyl Patient Examination Glove
510(k) Number K122396
Device Name POWERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
Applicant
Wealth on (Jiangsu) Co., Ltd.
5 Carey St.
Pennington,  NJ  08534
Applicant Contact CHARLES SHEN
Correspondent
Wealth on (Jiangsu) Co., Ltd.
5 Carey St.
Pennington,  NJ  08534
Correspondent Contact CHARLES SHEN
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received08/07/2012
Decision Date 01/31/2013
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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