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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 K133123
Device Name NON STERILE, POWEDER FREE BLUE NITRILE EXAMINATION GLOVES - 8623F
Applicant
Yty Industry (Manjung) Sdn Bhd
14004 Manor Rd.
P.O. Box 445
Phonex,  MD  21131
Applicant Contact ANDREW LOWERY
Correspondent
Yty Industry (Manjung) Sdn Bhd
14004 Manor Rd.
P.O. Box 445
Phonex,  MD  21131
Correspondent Contact ANDREW LOWERY
Regulation Number880.6250
Classification Product Code
LZA  
Date Received09/30/2013
Decision Date 05/30/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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