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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K994162
Device Name POWERED DENTAL POWDERED EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (75 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 Number880.6250
Classification Product Code
LYY  
Date Received12/09/1999
Decision Date 02/09/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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