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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vinyl Patient Examination Glove
510(k) Number K972624
Device Name POLY (VINYL) EXAM GLOVE, POWDER-FREE
Applicant
Copioumed Intl., Inc.
19001 S. Richfield # 185
Green Valley,  AZ  85614
Applicant Contact JANNA P TUCKER
Correspondent
Copioumed Intl., Inc.
19001 S. Richfield # 185
Green Valley,  AZ  85614
Correspondent Contact JANNA P TUCKER
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received07/14/1997
Decision Date 11/06/1997
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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