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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 K182575
Device Name Jaysun Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
Applicant
Jiangxi Jaysun Medcare Co., Ltd.
#1 Jaysun Rd., Penghuwan Industrial Park Pengze City,
Jiujiang,  CN 332708
Applicant Contact Zong Run
Correspondent
Beijing Easylink Co., Ltd.
Rm. F302 Bldg., 41, Jing Cheng Ya Ju
Ct.yard 6 Of Southern Dou Ge Zhuang
Beijing,  CN 100021
Correspondent Contact Chu Xiaoan
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received09/19/2018
Decision Date 05/24/2019
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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