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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 K131341
Device Name POWDER FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES
Applicant
Shijiazhuang Winful Plastic Co., Ltd.
Rm. 1606 Bldg. 1 Jianxiang Yuan No 209 Bei Si Huan Zhong Rd.
Haidian Dis
Beijing,  CN 100083
Applicant Contact CHU XIAOAN
Correspondent
Shijiazhuang Winful Plastic Co., Ltd.
Rm. 1606 Bldg. 1 Jianxiang Yuan No 209 Bei Si Huan Zhong Rd.
Haidian Dis
Beijing,  CN 100083
Correspondent Contact CHU XIAOAN
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received05/09/2013
Decision Date 02/06/2014
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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