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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K984249
Device Name SKINSENSE NITRILE POWDER-FREE SYNTHETIC MEDICAL EXAMINATION GLOVE
Applicant
London International Group, Inc.
P.O. Box 8308
2926 Columbia Hwy.
Dothan,  AL  36304
Applicant Contact NEIL ANDERSON
Correspondent
London International Group, Inc.
P.O. Box 8308
2926 Columbia Hwy.
Dothan,  AL  36304
Correspondent Contact NEIL ANDERSON
Regulation Number880.6250
Classification Product Code
LZA  
Date Received11/30/1998
Decision Date 05/04/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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