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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 K891223
Device Name PATIENT EXAMINATION GLOVES (LATEX)
Applicant
Sin Super Holdings Sdn Bhd
Lot 1185 Kamunting Industrial
Estate
34600 Kamunting, Perak,  MY
Applicant Contact BOK TEK
Correspondent
Sin Super Holdings Sdn Bhd
Lot 1185 Kamunting Industrial
Estate
34600 Kamunting, Perak,  MY
Correspondent Contact BOK TEK
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/07/1989
Decision Date 04/26/1989
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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