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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 K983828
Device Name NITRIKLEEN- NITRILE EXAMINATION GLOVE POWDER FREE
Applicant
Sinetimed Latex Sdn Bhd
Lot 118, Jalan Logam, 7
Kamunting Raya Indust. Estate
Taiping, Perak,  MY 34600
Applicant Contact A.S. TAN
Correspondent
Sinetimed Latex Sdn Bhd
Lot 118, Jalan Logam, 7
Kamunting Raya Indust. Estate
Taiping, Perak,  MY 34600
Correspondent Contact A.S. TAN
Regulation Number880.6250
Classification Product Code
LZA  
Date Received10/30/1998
Decision Date 01/21/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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