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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name medical glove, specialty
510(k) Number K032374
Device Name POWDER-FREE NITRILE PATIENT CHEMOTHERAPY EXAMINATION GLOVE, BLUE COLORED
Applicant
PERUSAHAAN GETAH ASAS SDN BHD
1301 DEFENSE HIGHWAY
GAMBRILLS,  MD  21054 -1928
Applicant Contact JAMES F LOGAN
Correspondent
PERUSAHAAN GETAH ASAS SDN BHD
1301 DEFENSE HIGHWAY
GAMBRILLS,  MD  21054 -1928
Correspondent Contact JAMES F LOGAN
Regulation Number880.6250
Classification Product Code
LZC  
Date Received08/01/2003
Decision Date 10/22/2003
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
Recalls CDRH Recalls
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