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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 K013302
Device Name DURAPRENE STERILE SYNTHETIC POWDER-FREE SURGICAL GLOVES WITH TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM
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 Received10/03/2001
Decision Date 12/17/2001
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
Predetermined Change
Control Plan Authorized		 No
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