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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 K891496
Device Name PATIENT EXAM GLOVES (LATEX) MFG. CHINA XINXING
Applicant
B.C. Young Intertrade Corp.
726 Arrow Grand Cir.
Covina,  CA  91722
Applicant Contact VERN NISHINA
Correspondent
B.C. Young Intertrade Corp.
726 Arrow Grand Cir.
Covina,  CA  91722
Correspondent Contact VERN NISHINA
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/16/1989
Decision Date 07/31/1989
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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