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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 K893098
Device Name VINYL EXAM GLOVES (MFG. TOPLAS INDUSTRIAL CO.)
Applicant
Jason Co.
1200 S. Jackson St. Suite 21
Seattle,  WA  98144
Applicant Contact JIMMY LIN
Correspondent
Jason Co.
1200 S. Jackson St. Suite 21
Seattle,  WA  98144
Correspondent Contact JIMMY LIN
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received04/14/1989
Decision Date 06/14/1989
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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