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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 K003197
Device Name VINYL, POWDER-FREE, PATIENT EXAMINATION GLOVES, YELLOW
Applicant
Kaohsiung Brothers Products Corp.
23 Kooshan 3rd Rd.
Kaohsiung,  TW 80414
Applicant Contact STONE CHEN
Correspondent
Kaohsiung Brothers Products Corp.
23 Kooshan 3rd Rd.
Kaohsiung,  TW 80414
Correspondent Contact STONE CHEN
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received10/12/2000
Decision Date 11/22/2000
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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