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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 K991205
Device Name ULTRADERM STERILE LATEX POWDERED SURGICAL SLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
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 Received04/09/1999
Decision Date 10/13/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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