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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 K896016
Device Name LATEX EXAMINATION GLOVES
Applicant
Sudinar Sdn Bhd
999, Solok Perusahaan 3
Kawasan Perindustrian Prai
13600 Butterworth,  MY
Applicant Contact WAN AMIR
Correspondent
Sudinar Sdn Bhd
999, Solok Perusahaan 3
Kawasan Perindustrian Prai
13600 Butterworth,  MY
Correspondent Contact WAN AMIR
Regulation Number880.6250
Classification Product Code
LYY  
Date Received10/17/1989
Decision Date 01/17/1990
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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