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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 K030164
Device Name NON-STERILE, POWDER-FREE, POLYMER COATED, NATURAL AND/OR VIOLET AND BLACK COLOR, LATEX EXAMINATION GLOVES WITH PROTEIN
Applicant
YTY INDUSTRY (MANJUNG) SDN. BHD.
198 AVENUE DE LA D'EMERALD
SPARKS,  NV  89434 -9550
Applicant Contact JANNA P TUCKER
Correspondent
YTY INDUSTRY (MANJUNG) SDN. BHD.
198 AVENUE DE LA D'EMERALD
SPARKS,  NV  89434 -9550
Correspondent Contact JANNA P TUCKER
Regulation Number880.6250
Classification Product Code
LYY  
Date Received01/16/2003
Decision Date 03/07/2003
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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