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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 K121992
Device Name POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLOR
Applicant
Xinwei (Shandong) Plastic and Rubber Products Co.,
12390 E. End Ave.
Chino,  CA  91710
Applicant Contact FRANK LIU
Correspondent
Xinwei (Shandong) Plastic and Rubber Products Co.,
12390 E. End Ave.
Chino,  CA  91710
Correspondent Contact FRANK LIU
Regulation Number880.6250
Classification Product Code
LZA  
Date Received07/06/2012
Decision Date 10/16/2012
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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