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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Medical Glove, Specialty
510(k) Number K905177
Device Name STAT(TM) GLOVE
Applicant
Success Builders Intl., Inc.
2990 S. Yellowstone Hwy.
Idaho Falls,  ID  83402
Applicant Contact CLAYTON RICH
Correspondent
Success Builders Intl., Inc.
2990 S. Yellowstone Hwy.
Idaho Falls,  ID  83402
Correspondent Contact CLAYTON RICH
Regulation Number880.6250
Classification Product Code
LZC  
Date Received11/19/1990
Decision Date 01/30/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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