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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgeon'S Gloves
510(k) Number K993349
Device Name NIL, SURGEON'S GLOVE - POWDER FREE
Applicant
Sri Anusham Rubber Industries Pvt., Ltd.
Pioneer Manikandan Bldg.
Vadasery, Nagercoil, Tn,  IN 629001
Applicant Contact N PARAMASIVAN
Correspondent
Sri Anusham Rubber Industries Pvt., Ltd.
Pioneer Manikandan Bldg.
Vadasery, Nagercoil, Tn,  IN 629001
Correspondent Contact N PARAMASIVAN
Regulation Number878.4460
Classification Product Code
KGO  
Date Received10/05/1999
Decision Date 11/23/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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