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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 K974518
Device Name NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES COLORED
Applicant
Yty Industry (Manjung) Sdn Bhd
Lot 2935b Kg Batu 9 Kebun Baru
Jalan Masjid Telok Panglima
Kuala Langat Selangor D.E.,  MY 42500
Applicant Contact LEONARD FRIER
Correspondent
Met Laboratories, Inc.
914 W. Patapsco Ave.
Baltimore,  MD  21230
Regulation Number880.6250
Classification Product Code
LYY  
Date Received12/02/1997
Decision Date 12/12/1997
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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