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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 K950450
Device Name POWDER FREE LATEX EXAMINATION GLOVES
Applicant
Rampart Glove Co.
11688 Wake Cir.
Cypress,  CA  91748
Applicant Contact JOHN POULTNEY
Correspondent
Rampart Glove Co.
11688 Wake Cir.
Cypress,  CA  91748
Correspondent Contact JOHN POULTNEY
Regulation Number880.6250
Classification Product Code
LYY  
Date Received02/03/1995
Decision Date 06/02/1995
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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