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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 K905515
Device Name ZOETIC GLOVES
Applicant
Janco Polymers Pvt., Ltd.
Plot # 18, Export Processing
Zone, Kochi, Kerala,
India,  IN
Applicant Contact JOSEPH
Correspondent
Janco Polymers Pvt., Ltd.
Plot # 18, Export Processing
Zone, Kochi, Kerala,
India,  IN
Correspondent Contact JOSEPH
Regulation Number880.6250
Classification Product Code
LYY  
Date Received12/10/1990
Decision Date 12/19/1990
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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