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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name surgeon's gloves
510(k) Number K010862
Device Name ULTRAFREE MAX STERILE LATEX POWEDER-FREE SURGICAL GLOVES WITH PROTEIN LABELING CLAIM, 50 PER GRAM OR LESS OF TOTAL WATER
Applicant
ALLEGIANCE HEALTHCARE CORP.
1500 WAUKEGAN RD. MPWM-1E
MCGAW PARK,  IL  60085
Applicant Contact ERICA SETHI
Correspondent
ALLEGIANCE HEALTHCARE CORP.
1500 WAUKEGAN RD. MPWM-1E
MCGAW PARK,  IL  60085
Correspondent Contact ERICA SETHI
Regulation Number878.4460
Classification Product Code
KGO  
Date Received03/22/2001
Decision Date 06/07/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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