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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 K930903
Device Name PROBE PERSONAL PREFERENCE NON-STER. PAT. EXAM.GLOV
Applicant
Glove India Private , Ltd.
C 7 Madras Export Proc. Zone
Tambaram, Madras-600 045
India,  IN
Applicant Contact D. M PRASAD
Correspondent
Glove India Private , Ltd.
C 7 Madras Export Proc. Zone
Tambaram, Madras-600 045
India,  IN
Correspondent Contact D. M PRASAD
Regulation Number880.6250
Classification Product Code
LYY  
Date Received02/23/1993
Decision Date 08/25/1993
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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