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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 K014278
Device Name LATEX SURGEONS GLOVE (POWDERED)
Applicant
Brightway Gloves Pvt. , Ltd.
Pioneer Manikandan Bldg.s
Vadasery, Nagar Coil
Tamil Nadu,  IN 629001
Applicant Contact N. PARAMASIVAN
Correspondent
Brightway Gloves Pvt. , Ltd.
Pioneer Manikandan Bldg.s
Vadasery, Nagar Coil
Tamil Nadu,  IN 629001
Correspondent Contact N. PARAMASIVAN
Regulation Number878.4460
Classification Product Code
KGO  
Date Received12/27/2001
Decision Date 05/14/2002
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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