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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 K894713
Device Name LATEX PATIENT EXAMINATION GLOVES
Applicant
Vailwood Products, L.P.
36 Vailwood Ct.
Danville,  CA  94526
Applicant Contact DAVID E HUNTER
Correspondent
Vailwood Products, L.P.
36 Vailwood Ct.
Danville,  CA  94526
Correspondent Contact DAVID E HUNTER
Regulation Number880.6250
Classification Product Code
LYY  
Date Received07/24/1989
Decision Date 11/28/1989
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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