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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 K974191
Device Name EVERGREEN NON-STERILE POWDERED LATEX EXAMINATION GLOVE
Applicant
Yty Industry (Manjung) Sdn Bhd
198 Ave. De La D'Emerald
Sparks,  NV  89434
Applicant Contact MOH UNG NANG
Correspondent
Met Laboratories, Inc.
914 W. Patapsco Ave.
Baltimore,  MD  21230
Correspondent Contact LEONARD FRIER
Regulation Number880.6250
Classification Product Code
LYY  
Date Received11/10/1997
Decision Date 12/24/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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