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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 K932550
Device Name POWDER FREE EXAMINATION GLOVES
Applicant
Unigloves , Ltd.
304-B E. Lawrence Blvd.
P.O. Box 1084
Avondale,  AZ  85323
Applicant Contact NEERAJ KUMAR
Correspondent
Unigloves , Ltd.
304-B E. Lawrence Blvd.
P.O. Box 1084
Avondale,  AZ  85323
Correspondent Contact NEERAJ KUMAR
Regulation Number880.6250
Classification Product Code
LYY  
Date Received05/26/1993
Decision Date 09/19/1994
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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