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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 K030200
Device Name POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, WHITE
Applicant
Kaohsiung Brothers Products Corp.
2631, N. Magnolia St.
Chicago,  IL  60614
Applicant Contact CHIEN LIN
Correspondent
Kaohsiung Brothers Products Corp.
2631, N. Magnolia St.
Chicago,  IL  60614
Correspondent Contact CHIEN LIN
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received01/21/2003
Decision Date 03/20/2003
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
Predetermined Change
Control Plan Authorized		 No
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