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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 K953379
Device Name HYPOALLERGENIC POWDERED AMBIDEXTROUS COAGULATN DIPPED LATEX EXAMINATION GLOVE
Applicant
Ansell, Inc.
1500 Industrial Rd.
Post Office Box 1252
Dothan,  AL  36302
Applicant Contact KAY SMITH
Correspondent
Ansell, Inc.
1500 Industrial Rd.
Post Office Box 1252
Dothan,  AL  36302
Correspondent Contact KAY SMITH
Regulation Number880.6250
Classification Product Code
LYY  
Date Received07/19/1995
Decision Date 09/27/1995
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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