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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
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