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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 K030997
Device Name POWDERED VINYL EXAM GLOVES, WHITE
Applicant
HEYUAN HONGLI INDUSTRIES, INC.
198 AVENUE DE LA D'EMERALD
SPARKS,  NV  89434 -9550
Applicant Contact JANNA P TUCKER
Correspondent
HEYUAN HONGLI INDUSTRIES, INC.
198 AVENUE DE LA D'EMERALD
SPARKS,  NV  89434 -9550
Correspondent Contact JANNA P TUCKER
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received03/28/2003
Decision Date 05/02/2003
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
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