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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 K892978
Device Name TIGER PATIENT EXAM GLOVES
Applicant
Daesung America Co., Inc.
Two Executive Dr.
5th Floor
Fort Lee,  NJ  07024
Applicant Contact DONG-HWAN, KIM
Correspondent
Daesung America Co., Inc.
Two Executive Dr.
5th Floor
Fort Lee,  NJ  07024
Correspondent Contact DONG-HWAN, KIM
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/12/1989
Decision Date 08/29/1989
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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