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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 K892623
Device Name PATIENT EXAMINATION GLOVES (LATEX)
Applicant
Globe Ent., Inc.
8345 W. Little York, # 1
Houston,  TX  77040
Applicant Contact CAROL MUSICK
Correspondent
Globe Ent., Inc.
8345 W. Little York, # 1
Houston,  TX  77040
Correspondent Contact CAROL MUSICK
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/10/1989
Decision Date 09/11/1989
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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