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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 K912392
Device Name PROBE LATEX EXAMINATION GLOVES - STERILE
Applicant
Glovetex Industries
C-7, Madras Export Processing
Zone, Tambaram,
Madras-600 045 (India),  IN
Applicant Contact PRASAD
Correspondent
Glovetex Industries
C-7, Madras Export Processing
Zone, Tambaram,
Madras-600 045 (India),  IN
Correspondent Contact PRASAD
Regulation Number880.6250
Classification Product Code
LYY  
Date Received05/03/1991
Decision Date 09/23/1991
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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