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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 K881191
Device Name REGAL LATEX SURGICAL GLOVES
Applicant
Maxcare, Inc.
1626 Delaware Ave.
Des Moines,  IA  50317
Applicant Contact PAUL SINGH
Correspondent
Maxcare, Inc.
1626 Delaware Ave.
Des Moines,  IA  50317
Correspondent Contact PAUL SINGH
Regulation Number878.4460
Classification Product Code
KGO  
Date Received03/21/1988
Decision Date 04/01/1988
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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