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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 K902617
Device Name PATIENT EXAMINATION GLOVES
Applicant
Unicorn Latex, Ltd.
Raymar
16360 Broadway Ave.
Cleveland,  OH  44137
Applicant Contact SHIV K AGGARWAL
Correspondent
Unicorn Latex, Ltd.
Raymar
16360 Broadway Ave.
Cleveland,  OH  44137
Correspondent Contact SHIV K AGGARWAL
Regulation Number880.6250
Classification Product Code
LYY  
Date Received06/13/1990
Decision Date 08/10/1990
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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