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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 K021743
Device Name (MULTIPLE LABELS) POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: YELLOW
Applicant
Copioumed Intl., Inc.
198 Ave. De La D'Emerald
Sparks,  NV  89434 -9550
Applicant Contact JANNA P TUCKER
Correspondent
Copioumed Intl., Inc.
198 Ave. De La D'Emerald
Sparks,  NV  89434 -9550
Correspondent Contact JANNA P TUCKER
Regulation Number880.6250
Classification Product Code
LZA  
Date Received05/28/2002
Decision Date 06/10/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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