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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 K892463
Device Name PATIENT EXAMINATION GLOVES (LATEX)
Applicant
Civilized Lawana Co. , Ltd.
41/7 Sukapiban 6, Petkasem
Rd., Sampran
Nakorn, Pathom,  TH 73110
Applicant Contact SUWAN FU
Correspondent
Civilized Lawana Co. , Ltd.
41/7 Sukapiban 6, Petkasem
Rd., Sampran
Nakorn, Pathom,  TH 73110
Correspondent Contact SUWAN FU
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/07/1989
Decision Date 07/14/1989
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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