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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 K980785
Device Name STERILE, POWDERFREE LATEX EXAMINATION GLOVE
Applicant
London Intl., LLC
2926 Columbia Hwy.
P.O. Box 8308
Dothan,  AL  36304
Applicant Contact NEIL ANDERSON
Correspondent
London Intl., LLC
2926 Columbia Hwy.
P.O. Box 8308
Dothan,  AL  36304
Correspondent Contact NEIL ANDERSON
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/02/1998
Decision Date 06/10/1998
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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