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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 K024184
Device Name POWDER-FREE COATED NITRILE 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
LZA  
Date Received12/19/2002
Decision Date 01/14/2003
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
Predetermined Change
Control Plan Authorized		 No
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