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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 K922116
Device Name POWDER FREE NITRILE GLOVE
Applicant
Hpi, Inc.
931 SEcond Ave. SE
Fayette,  AL  35555
Applicant Contact CAROL ESSARY
Correspondent
Hpi, Inc.
931 SEcond Ave. SE
Fayette,  AL  35555
Correspondent Contact CAROL ESSARY
Regulation Number878.4460
Classification Product Code
KGO  
Date Received03/12/1992
Decision Date 02/08/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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