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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 K905624
Device Name PROBE SURGEON'S GLOVES- STERILE
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 Number878.4460
Classification Product Code
KGO  
Date Received12/14/1990
Decision Date 04/08/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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