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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 K925537
Device Name POWDER-FREE LATEX EXAMINATION GLOVES
Applicant
Safetytech Sdn. Bhd.
C/O Lowenkamp Intl., Inc.
P.O. Box 878
Haz;Ejirst,  MS  39083
Applicant Contact WILLIAM C LOWENKAMP
Correspondent
Safetytech Sdn. Bhd.
C/O Lowenkamp Intl., Inc.
P.O. Box 878
Haz;Ejirst,  MS  39083
Correspondent Contact WILLIAM C LOWENKAMP
Regulation Number880.6250
Classification Product Code
LYY  
Date Received11/02/1992
Decision Date 05/13/1993
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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