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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 K011286
Device Name POWDER-FREE NITRILE EXAM GLOVE, BLUE
Applicant
Ningbo Yujiang Plastic & Rubber Co. , Ltd.
198 Ave. De La D'Emerald
Sparks,  NV  89434
Applicant Contact JANNA P TUCKER
Correspondent
Ningbo Yujiang Plastic & Rubber Co. , Ltd.
198 Ave. De La D'Emerald
Sparks,  NV  89434
Correspondent Contact JANNA P TUCKER
Regulation Number880.6250
Classification Product Code
LZA  
Date Received04/27/2001
Decision Date 05/16/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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