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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 K896938
Device Name EPVC PATIENT EXAMINATION GLOVE
Applicant
UNITED ORIENT, INC.
59 WOODSIDE DR.
PENFIELD,  NY  14526
Applicant Contact H. K LING
Correspondent
UNITED ORIENT, INC.
59 WOODSIDE DR.
PENFIELD,  NY  14526
Correspondent Contact H. K LING
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received12/13/1989
Decision Date 03/27/1990
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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