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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 K102362
Device Name POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
Applicant
Jiangsu Huayuan Gloves Co., Ltd.
#68 Jingyi Rd., Chengdong
New District
Dongtai,  CN 224249
Applicant Contact YU BANG TING
Correspondent
Jiangsu Huayuan Gloves Co., Ltd.
#68 Jingyi Rd., Chengdong
New District
Dongtai,  CN 224249
Correspondent Contact YU BANG TING
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received08/19/2010
Decision Date 10/04/2010
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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