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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 K891447
Device Name PATIENT EXAMINATION GLOVES (LATEX)
Applicant
Lily Corp.
8700 Long Pt.
Unit #205
Houston,  TX  77080
Applicant Contact SHIRLEY HSU
Correspondent
Lily Corp.
8700 Long Pt.
Unit #205
Houston,  TX  77080
Correspondent Contact SHIRLEY HSU
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/15/1989
Decision Date 03/23/1989
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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