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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 K945767
Device Name POWDER FREE, HYPOALLERGENIC AMBIDEXTROUS PATIENT EXAMINATION GLOVES
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 Received11/21/1994
Decision Date 03/02/1995
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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