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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 K143346
Device Name Powder-Free White Vinyl Patient Examination Gloves
Applicant
Zibo Changda Plastic Products Company, Limited
Yumin Rd.
Zibo,  CN 255000
Applicant Contact Coco Kou
Correspondent
Zibo Changda Plastic Products Company, Limited
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
LYZ  
Date Received11/21/2014
Decision Date 07/22/2015
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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