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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 K895754
Device Name LATEX PATIENT EXAMINATION GLOVES
Applicant
Frontline Latex Products Pvt. , Ltd.
71-B, Sipcot Industrial Estate
Hosur 635126
India,  IN
Applicant Contact S SETHURAMAN
Correspondent
Frontline Latex Products Pvt. , Ltd.
71-B, Sipcot Industrial Estate
Hosur 635126
India,  IN
Correspondent Contact S SETHURAMAN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received09/28/1989
Decision Date 12/21/1989
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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