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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 K897187
Device Name PROBE PATIENT EXAMINATION GLOVES
Applicant
Glove India Pvt. , Ltd.
C-7, Madras Export Processing
Tambaram
Madras-600 045 India,  IN
Applicant Contact PRASAD
Correspondent
Glove India Pvt. , Ltd.
C-7, Madras Export Processing
Tambaram
Madras-600 045 India,  IN
Correspondent Contact PRASAD
Regulation Number880.6250
Classification Product Code
LYY  
Date Received12/28/1989
Decision Date 02/13/1990
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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