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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 K141304
Device Name YONGXIN NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR
Applicant
Yongxin Healthcare Co., Ltd.
Rm. 1606 Bldg. 1. Jianxiang Yuan # 209
Bei Si Huan Zhong Rd., Haidian Dis
Beijing,  CN 100083
Applicant Contact CHU XIAOAN
Correspondent
Yongxin Healthcare Co., Ltd.
Rm. 1606 Bldg. 1. Jianxiang Yuan # 209
Bei Si Huan Zhong Rd., Haidian Dis
Beijing,  CN 100083
Correspondent Contact CHU XIAOAN
Regulation Number880.6250
Classification Product Code
LZA  
Date Received05/19/2014
Decision Date 12/12/2014
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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