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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 K001924
Device Name COATED STERILE LATEX POWDEER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM OR LESS0
Applicant
ALLEGIANCE HEALTHCARE CORP.
1500 WAUKEGAN RD.- K
MCGRAW PARK,  IL  60085
Applicant Contact ERICA SETHI
Correspondent
ALLEGIANCE HEALTHCARE CORP.
1500 WAUKEGAN RD.- K
MCGRAW PARK,  IL  60085
Correspondent Contact ERICA SETHI
Regulation Number878.4460
Classification Product Code
KGO  
Date Received06/23/2000
Decision Date 07/14/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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