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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name vinyl patient examination glove
510(k) Number K032323
Device Name BROTHERS POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, YELLOW
Applicant
LONG FIRST (XIAMEN) PLASTICS CO., LTD.
2631 N. MAGNOLIA STREET
CHICAGO,  IL  60614
Applicant Contact CHIEN LIN
Correspondent
LONG FIRST (XIAMEN) PLASTICS CO., LTD.
2631 N. MAGNOLIA STREET
CHICAGO,  IL  60614
Correspondent Contact CHIEN LIN
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received07/28/2003
Decision Date 10/07/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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