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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 K891841
Device Name LATEX EXAM GLOVES (MFG. YEOU JIH INDUSTRIAL CO.)
Applicant
Neo-Sigma, Inc.
10605 Boomer Cir. #101
Dallas,  TX  75238
Applicant Contact ALEX LAI
Correspondent
Neo-Sigma, Inc.
10605 Boomer Cir. #101
Dallas,  TX  75238
Correspondent Contact ALEX LAI
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/28/1989
Decision Date 05/31/1989
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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