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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 K990013
Device Name EVERGREEN NON-STERILE POWDER-FREE, COLORED NITRILE EXAMINATION GLOVES
Applicant
Yty Industry (Manjung) Sdn Bhd
P.O. Box 4341
Crofton,  MD  21114
Applicant Contact E J SMITH
Correspondent
Yty Industry (Manjung) Sdn Bhd
P.O. Box 4341
Crofton,  MD  21114
Correspondent Contact E J SMITH
Regulation Number880.6250
Classification Product Code
LZA  
Date Received01/04/1999
Decision Date 03/23/1999
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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