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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 K092109
Device Name POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
Applicant
Zhangjiangang All Fine Rubber-Plastic Products Co.
Rm.1606, Bldg. 1, Jian Xiang
Yuan #209 Bei Sihuan Zong Rd.
Beijing,  CN 100083
Correspondent
Zhangjiangang All Fine Rubber-Plastic Products Co.
Rm.1606, Bldg. 1, Jian Xiang
Yuan #209 Bei Sihuan Zong Rd.
Beijing,  CN 100083
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received07/14/2009
Decision Date 10/09/2009
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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