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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 K926318
Device Name PATIENT EXAMINATION GLOVES
Applicant
I Ching Ent., Inc.
801 W. 49th St.
Hialeah,  FL  33012
Applicant Contact LISETTE MARTINEZ
Correspondent
I Ching Ent., Inc.
801 W. 49th St.
Hialeah,  FL  33012
Correspondent Contact LISETTE MARTINEZ
Regulation Number880.6250
Classification Product Code
LYY  
Date Received12/15/1992
Decision Date 09/09/1993
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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