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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, NO. PRT. INDU.
PORT KLANG,  MY 42000
Applicant Contact JAMES H LALE
Correspondent
BIOPRO (M) SDN BHD
LOT14, PT.4204 LINGKARN SULTN
HISHAMUDDIN, NO. 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
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