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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 K031104
Device Name POWDERED VINYL EXAM GLOVES, WHITE
Applicant
GLORMED INTL., INC.
198 AVENUE DE LA D'EMERALD
SPARKS,  NV  89434
Applicant Contact JANNA P TUCKER
Correspondent
GLORMED INTL., INC.
198 AVENUE DE LA D'EMERALD
SPARKS,  NV  89434
Correspondent Contact JANNA P TUCKER
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received04/07/2003
Decision Date 06/10/2003
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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