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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 K921376
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 K. Y CHEAH
Correspondent
Seal Polymer Industries Bhd.
# 28-B Jalan Ss15/8
Suubang Jaya, 47500 Petaling
Jaya Selangor W. Malaysia,  MY
Correspondent Contact K. Y CHEAH
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/20/1992
Decision Date 06/15/1992
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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