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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K111248
Device Name NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVES (ORIGINAL BLUE, COBALT BLUE)
Applicant
Yty Industry (Manjung) Sdn Bhd
198 Ave. De La D'Emerald
Sparks,  NV  89434
Applicant Contact JANNA TUCKER
Correspondent
Yty Industry (Manjung) Sdn Bhd
198 Ave. De La D'Emerald
Sparks,  NV  89434
Correspondent Contact JANNA TUCKER
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Code
LZC  
Date Received05/03/2011
Decision Date 12/01/2011
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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