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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 K082648
Device Name POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
Applicant
Tangshan Dar Plastic & Rubber Products Co. , Ltd.
Rm.1606 Bldg.1, Jianxiang Yuan
#209 Bei Si Huan Zhong Rd.
Beijing,  CN 10083
Applicant Contact WANG JINCHENG
Correspondent
Tangshan Dar Plastic & Rubber Products Co. , Ltd.
Rm.1606 Bldg.1, Jianxiang Yuan
#209 Bei Si Huan Zhong Rd.
Beijing,  CN 10083
Correspondent Contact WANG JINCHENG
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received09/11/2008
Decision Date 09/25/2009
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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