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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 K952473
Device Name POWDER-FREE LATEX EXAMINATION GLOVE
Applicant
M.M.R. Gloves Private , Ltd.
748 Mount Rd.
Madras,  IN 600 002
Applicant Contact R ASHOKAN
Correspondent
M.M.R. Gloves Private , Ltd.
748 Mount Rd.
Madras,  IN 600 002
Correspondent Contact R ASHOKAN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received05/26/1995
Decision Date 10/12/1995
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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