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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 BUILDINGS
VADASERY, NAGAR COIL
TAMIL NADU,  IN 629001
Applicant Contact N. PARAMASIVAN
Correspondent
BRIGHTWAY GLOVES PVT. LTD.
PIONEER MANIKANDAN BUILDINGS
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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