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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 K892686
Device Name PATIENT EXAM GLOVES (MFG. POLYMINT INDUSTRIAL CO.)
Applicant
Intl. Visco Group
19 Spear Rd.
Suite 107
Ramsey,  NJ  07446
Applicant Contact VICTOR LIN
Correspondent
Intl. Visco Group
19 Spear Rd.
Suite 107
Ramsey,  NJ  07446
Correspondent Contact VICTOR LIN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/11/1989
Decision Date 05/25/1989
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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