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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 K896527
Device Name POWDER-FREE DANTEX VINYL EXAMINATION GLOVES
Applicant
DAN CO., LTD.
P.O. BOX 68-1032
TAIPEI, TAIWAN,  TW
Applicant Contact CHEN
Correspondent
DAN CO., LTD.
P.O. BOX 68-1032
TAIPEI, TAIWAN,  TW
Correspondent Contact CHEN
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received11/09/1989
Decision Date 03/08/1990
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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