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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 K891731
Device Name PATIENT EXAMINATION GLOVES (LATEX)
Applicant
Southern Medical Products, Inc.
3801 Empedrado St.
Tampa,  FL  33629
Applicant Contact DONALD E JAMES
Correspondent
Southern Medical Products, Inc.
3801 Empedrado St.
Tampa,  FL  33629
Correspondent Contact DONALD E JAMES
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/22/1989
Decision Date 08/31/1989
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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