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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Patient Examination Glove
510(k) Number K831564
Device Name ORTHOPEDIC SURGICAL GLOVE
Applicant
Ansell, Inc.
1500 Industrial Rd.
Dothan,  AL  36303
Correspondent
Ansell, Inc.
1500 Industrial Rd.
Dothan,  AL  36303
Regulation Number880.6250
Classification Product Code
FMC  
Date Received05/16/1983
Decision Date 07/12/1983
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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