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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 K892287
Device Name PATIENT EXAMINATION GLOVES (LATEX)
Applicant
Supermax Sdn Bhd
# 8, Lrg Ss 13/3e, Subang
Jaya Industrial Est., 47500
Petaling Jaya, Selangor,  MY
Applicant Contact STANLEY THAI
Correspondent
Supermax Sdn Bhd
# 8, Lrg Ss 13/3e, Subang
Jaya Industrial Est., 47500
Petaling Jaya, Selangor,  MY
Correspondent Contact STANLEY THAI
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/06/1989
Decision Date 01/10/1990
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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