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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 K930407
Device Name POWDER-FREE LATEX EXAMINATION GLOVES
Applicant
Influx Pacific Sdn. Bhd.
C/O Lowenkamp Intl., Inc.
P.O. Box 878
Haz;Ejirst,  MS  39083
Applicant Contact WILLIAM C LOWENKAMP
Correspondent
Influx Pacific 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 Received01/26/1993
Decision Date 08/25/1993
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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