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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 K112610
Device Name SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (AND MULTIPLE LABELS)
Applicant
Inpro Technology Device Factory
No 10-1, Xing'An Rd. E.
Linqu
Weifang, Shandong,  CN 262600
Applicant Contact MEIXIA WANG
Correspondent
Inpro Technology Device Factory
No 10-1, Xing'An Rd. E.
Linqu
Weifang, Shandong,  CN 262600
Correspondent Contact MEIXIA WANG
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received09/07/2011
Decision Date 12/05/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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