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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 K980677
Device Name NITRILE EXAM GLOVE, POWDER FREE
Applicant
Ningbo Yujiang Plastic & Rubber Co. , Ltd.
19001 S. Richfield # 185
Green Valley,  AZ  85614
Applicant Contact JANNA P TUCKER
Correspondent
Ningbo Yujiang Plastic & Rubber Co. , Ltd.
19001 S. Richfield # 185
Green Valley,  AZ  85614
Correspondent Contact JANNA P TUCKER
Regulation Number880.6250
Classification Product Code
LZA  
Date Received02/20/1998
Decision Date 03/16/1998
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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