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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 K992358
Device Name CORRECT TOUCH POWDER FREE 911 LATEX EXAMINATION GLOVES, (BLUE)
Applicant
Biopro (M) Sdn Bhd
Lot14, Pt.4204 Lingkarn Sultn
Hishamuddin, # Prt. Indu.
Port Klang,  MY 42000
Applicant Contact JIM LALE
Correspondent
Biopro (M) Sdn Bhd
Lot14, Pt.4204 Lingkarn Sultn
Hishamuddin, # Prt. Indu.
Port Klang,  MY 42000
Correspondent Contact JIM LALE
Regulation Number880.6250
Classification Product Code
LYY  
Date Received07/14/1999
Decision Date 09/10/1999
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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