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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 K915607
Device Name PATIENT EXAMINATION GLOVES
Applicant
Seal Polymer Industries Bhd.
# 28-B Jalan Ss15/8
Suubang Jaya, 47500 Petaling
Jaya Selangor W. Malaysia,  MY
Applicant Contact MUI FAH
Correspondent
Seal Polymer Industries Bhd.
# 28-B Jalan Ss15/8
Suubang Jaya, 47500 Petaling
Jaya Selangor W. Malaysia,  MY
Correspondent Contact MUI FAH
Regulation Number880.6250
Classification Product Code
LYY  
Date Received12/16/1991
Decision Date 03/04/1993
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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