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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 K113194
Device Name POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE COLOR
Applicant
Suqian Ruijang Medical Supplies Co., Ltd.
1 Jian Xiang Yuan # 209
Bei Si Huan Zhong Rd. Hai Di
Chu Xiaoan,  CN 100083
Applicant Contact CHU XIAOAN
Correspondent
Suqian Ruijang Medical Supplies Co., Ltd.
1 Jian Xiang Yuan # 209
Bei Si Huan Zhong Rd. Hai Di
Chu Xiaoan,  CN 100083
Correspondent Contact CHU XIAOAN
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received10/31/2011
Decision Date 05/14/2012
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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