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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 K022765
Device Name NITRILE POWDER-FREE EXAMINATION GLOVES
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 Number880.6250
Classification Product Code
LZA  
Date Received08/20/2002
Decision Date 10/11/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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