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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 K120358
Device Name POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
Applicant
Hongxin Plastic Products Co., Ltd.
Rm.1606 Bldg., 1 Jian Xiang
Yuan # 209 Bei Si Huan Zhong
Road Hai Di, Beijing,  CN 100083
Applicant Contact CHU XIAOAN
Correspondent
Hongxin Plastic Products Co., Ltd.
Rm.1606 Bldg., 1 Jian Xiang
Yuan # 209 Bei Si Huan Zhong
Road Hai Di, Beijing,  CN 100083
Correspondent Contact CHU XIAOAN
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received02/06/2012
Decision Date 03/06/2012
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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