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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 K920059
Device Name ULTRASAFE
Applicant
Ultrawin Sdn Bhd
12a Taman Ros, Jalan Sultan
Abdullah, 3600 Teluk Intan,
Malaysia,  MY
Applicant Contact S. H MAH
Correspondent
Ultrawin Sdn Bhd
12a Taman Ros, Jalan Sultan
Abdullah, 3600 Teluk Intan,
Malaysia,  MY
Correspondent Contact S. H MAH
Regulation Number880.6250
Classification Product Code
LYY  
Date Received01/06/1992
Decision Date 03/11/1992
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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