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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 K892313
Device Name PATIENT EXAMINATION GLOVES (LATEX)
Applicant
Glove Lines Private , Ltd.
5, Sylvan Lodge Colony
Kilpauk Madras-600 010
Tamil Nadu, India,  IN
Applicant Contact MR. P SUBBARAJ
Correspondent
Glove Lines Private , Ltd.
5, Sylvan Lodge Colony
Kilpauk Madras-600 010
Tamil Nadu, India,  IN
Correspondent Contact MR. P SUBBARAJ
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/06/1989
Decision Date 10/13/1989
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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