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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K020868
Device Name CASHMERE NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES (WHITE)
Applicant
Seal Polymer Industries Bhd.
Lt 72706, Jalan Lahat, Kawasan
Perindustrian Bukit Merah
Lahat, Ipoh, Perak,  MY 31500
Applicant Contact CHUN CHOOI FONG
Correspondent
Seal Polymer Industries Bhd.
Lt 72706, Jalan Lahat, Kawasan
Perindustrian Bukit Merah
Lahat, Ipoh, Perak,  MY 31500
Correspondent Contact CHUN CHOOI FONG
Regulation Number880.6250
Classification Product Code
LZA  
Date Received03/18/2002
Decision Date 04/22/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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