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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K964845
Device Name JINHUA LATEX EXAM GLOVE, POWDER FREE WITH PROTEIN LABELING
Applicant
Jinhua Latex Products Factory
19001 S. Richfield # 185
Green Valley,  AZ  85614
Applicant Contact JANNA TUCKER
Correspondent
Jinhua Latex Products Factory
19001 S. Richfield # 185
Green Valley,  AZ  85614
Correspondent Contact JANNA TUCKER
Regulation Number880.6250
Classification Product Code
LYY  
Date Received12/03/1996
Decision Date 02/27/1997
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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