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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 K110247
Device Name POWDER FREE NUTRILE PATIENT EXAMINATION GLOVES, BLUE COLOR
Applicant
Jiangsu Dongling Plastic & Rubber Co., Ltd.
Rm. 1606 Bldg. 1 Jian Xian
Yuan #209 Bei Si Huan Zhong
Rd. Hai Di Beijing,  CN 100083
Applicant Contact CHU XIAOAN
Correspondent
Jiangsu Dongling Plastic & Rubber Co., Ltd.
Rm. 1606 Bldg. 1 Jian Xian
Yuan #209 Bei Si Huan Zhong
Rd. Hai Di Beijing,  CN 100083
Correspondent Contact CHU XIAOAN
Regulation Number880.6250
Classification Product Code
LZA  
Date Received01/28/2011
Decision Date 06/10/2011
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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