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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 K024355
Device Name EVERGREEN NON-STERILE POWDERED NATURAL OR COLORED LATEX EXAMINATION GLOVE
Applicant
Yty Industry (Manjung) Sdn Bhd
198 Ave. De La D'Emerald
Sparks,  NV  89434 -9550
Applicant Contact JANNA P TUCKER
Correspondent
Yty Industry (Manjung) Sdn Bhd
198 Ave. De La D'Emerald
Sparks,  NV  89434 -9550
Correspondent Contact JANNA P TUCKER
Regulation Number880.6250
Classification Product Code
LYY  
Date Received12/30/2002
Decision Date 02/03/2003
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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