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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vinyl Patient Examination Glove
510(k) Number K891945
Device Name PATIENT EXAMINATION GLOVES (VINYL)
Applicant
Libent Co., Ltd.
3900 Veterans Memorial
Hwy.
Bohemia,  NY  11716
Applicant Contact MICHAEL WONG
Correspondent
Libent Co., Ltd.
3900 Veterans Memorial
Hwy.
Bohemia,  NY  11716
Correspondent Contact MICHAEL WONG
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received03/28/1989
Decision Date 05/12/1989
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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