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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 K902459
Device Name LATEX EXAMINATION GLOVES
Applicant
Yue XI State Farms Latex Products United Corp.
C/O Henchman International,Inc
320 Valley Dr., 2nd Floor
Brisbane,  CA  94005
Applicant Contact CHIU
Correspondent
Yue XI State Farms Latex Products United Corp.
C/O Henchman International,Inc
320 Valley Dr., 2nd Floor
Brisbane,  CA  94005
Correspondent Contact CHIU
Regulation Number880.6250
Classification Product Code
LYY  
Date Received06/04/1990
Decision Date 06/22/1990
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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