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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 K951940
Device Name PATIENT EXAMINATION GLOVE
Applicant
Lowenkamp Intl., Inc.
13022 Monticello Rd.
P.O. Box 878
Hazlehurst,  MS  39083
Applicant Contact CHONG TEO
Correspondent
Lowenkamp Intl., Inc.
13022 Monticello Rd.
P.O. Box 878
Hazlehurst,  MS  39083
Correspondent Contact CHONG TEO
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/25/1995
Decision Date 06/28/1995
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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