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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K994276
Device Name BIOPRO, NITRILON, CORRECT TOUCH- NITRILE POWDERED EXAMINATION GLOVES (GREEN/ PURPLE)
Applicant
Biopro (M) Sdn Bhd
Lot14, Pt.4204 Lingkarn Sultn
Hishamuddin, # Prt. Indu.
Port Klang,  MY 42000
Applicant Contact JAMES H LALE
Correspondent
Biopro (M) Sdn Bhd
Lot14, Pt.4204 Lingkarn Sultn
Hishamuddin, # Prt. Indu.
Port Klang,  MY 42000
Correspondent Contact JAMES H LALE
Regulation Number880.6250
Classification Product Code
LZA  
Date Received12/20/1999
Decision Date 10/20/2000
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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