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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 K933288
Device Name POWDERFREE LATEX EXAMINATION GLOVES
Applicant
Liwe Trading
45 Jalan Ss2/104
Petaling Jaya,  MY 47300
Applicant Contact W. C LIM
Correspondent
Liwe Trading
45 Jalan Ss2/104
Petaling Jaya,  MY 47300
Correspondent Contact W. C LIM
Regulation Number880.6250
Classification Product Code
LYY  
Date Received07/06/1993
Decision Date 08/17/1994
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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