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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 K983998
Device Name POWDER FREE LATEX EXAMINATION GLOVES
Applicant
Sri Anusham Rubber Industries Pvt., Ltd.
P.O. Box 5206
Pleasanton,  CA  94566
Applicant Contact LATHA KUMARASWAMY
Correspondent
Sri Anusham Rubber Industries Pvt., Ltd.
P.O. Box 5206
Pleasanton,  CA  94566
Correspondent Contact LATHA KUMARASWAMY
Regulation Number880.6250
Classification Product Code
LYY  
Date Received11/09/1998
Decision Date 01/21/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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